Method and control unit for medication administering devices

ABSTRACT

A method and control unit for medication administering devices. The first aspect of the present invention is automatic programming of the scheduled events. The second aspect is simple user-request expression. The third aspect is guided user operation. The forth aspect is automatic medication-storage mapping. The fifth aspect is no clock setting. Prior art systems typically require the user to figure out a loading-scheduling plan, follow the plan to load the medications, program the scheduled events and tell the system how the medications are stored (manual medication-storage mapping). The system of the present invention does the opposite: it figures out the loading-scheduling plan, guides the user to load the medications, program the scheduled events, and establishes medication-storage mapping, all automatically. The system of the present invention is extremely easy to use, and vision-impaired users can easily use it.

BACKGROUND OF THE INVENTION

1. Field of Invention

This invention relates to managing and administering medications,especially to automated system for managing and administeringmedications.

2. Description of Prior Art

Presently, a doctor prescribes medication for a patient by writing on astandard prescription form, calling a prescription-filling facility, orentering into a specialized computer system (such as ComputerizedPhysician Order Entry, or CPOE) with the prescription information, whichnormally includes the doctor's information, the patient's information,the medication identifier (name), and the usage information. The usageinformation usually includes schedule (e.g., one unit dose everymorning, one unit dose every four hours, etc.), unit dosage (e.g., threetablets, 10 ml, etc.), and total daily dosage (e.g., 9 tablets, 40 ml.,three unit doses, etc.).

For an inpatient, the prescription is usually filled by an in-hospitalmedication administration unit, and a nurse administers each unit-dosemedication to the patient following the usage information.

For an outpatient, the prescription is usually filled by a pharmacy, anda pharmacist enters the prescription information into the pharmacy'scomputer system. The pharmacy's computer system prints a medicationlabel with human-readable medication information (including medicationidentifier and the usage information, to be affixed on the container orbag). The patient has to follow the usage information to take themedication.

Taking a wrong medication, with a wrong dosage, or at a wrong time couldresult in ineffective treatment, complication, or even death. Manymethods, systems, and devices have been developed or proposed in priorart to help nurses and patients adhere to usage information.

The healthcare facilities (hospitals, nursing homes, etc.) have adoptedregulations and procedures in administering medication. According to theprior art, there are medication-administering systems for healthcarefacilities, where the computer matches patient identification withprescribed medication before administering a unit-dose medication. TheFDA has ruled (effective in 2006) that healthcare facilities must usebarcode for patient identification matching.

For home-consumed medications, the responsibility for following usageinformation falls completely on the patient or the family members. Inaddition to prescription medications (Rx), a person may also takeover-the-counter (OTC) medications and dietary supplements, which alsohave their own usage information. That further complicates the matter.

For simplicity and definiteness, unless otherwise specified, the term“medication” will in general include Rx, OTC, dietary supplements, withall application types (intake, topical, injection, inhaler, etc.) in allforms (liquid, gaseous, ornament, powder, pill, capsule, etc.). The term“user” will be used to refer to a person who takes medication. The term“scheduled event” will generally refer to an event that is scheduled totake place at a specified moment, but mostly it will refer to a unitdose of certain medication at a scheduled time.

According to the prior art, a user can choose one or several devicesdescribed in the following to assist him/her adhere to usage informationat home.

A user can use a bulk medication organizer. A bulk medication organizerhas multiple storage compartments, each for a type of medication.Examples of prior art designs include: U.S. patent application Pub. No.2002/0130138 and 2001/0002025, U.S. Pat. Nos. 4,785,932 and 4,638,923.Bulk medication organizers represent the design of the lowest automationamong all prior art designs. It is just slightly more organized thanleaving medications in their original containers. Besides specificshortcomings of each individual design, bulk medication organizerssuffer from the following common disadvantages:

-   (A1) They provide very limited help.-   (A2) User has to label each storage compartment with usage    information.-   (A3) User has to keep time and track scheduled events with other    means.

A user can use a dose-compartment medication organizer. Adose-compartment medication organizer has multiple dose compartments,each holding one or several medications to be taken at same time.Examples of prior art designs include: U.S. patent application Pub. No.2005/0109658 and 2004/0256406, U.S. Pat. Nos. 6,554,136, 6,338,535, and5,838,224. Besides the specific shortcomings of each individual design,dose-compartment medication organizers suffer from the following commondisadvantages:

-   (B1) User has to figure out a loading-scheduling plan according to    the usage information.-   (B2) User has to follow the loading-scheduling plan to load the    medications into the dose compartments.-   (B3) Loading becomes dramatically complicated and tricky as the    number of medications increases.-   (B4) Practically they are not suitable for medications that require    precise timing, or have very different or complex schedules.-   (B5) It is very difficult to add a new medication since user has to    find an existing group with compatible schedule and identify the    corresponding dose compartments.-   (B6) It is difficult to delete (cancel) a medication since the user    has to search all dose compartments for that medication.-   (B7) User has to label each dose compartment with schedule except    for very simple and regular schedules (e.g., every morning).-   (B8) User has to keep time and track the scheduled events with other    means.

A user can use a medication reminder. A medication reminder producesvisual, audible, or tactile alarm for scheduled events to remind theuser. Examples of prior art designs include: U.S. patent applicationPub. No. 2005/0150805, 2005/0041531, and 2003/0146848, and U.S. Pat. No.6,845,064. The medication reminder may be equipped with a display orspeaker to indicate the medication and unit dosage to be taken. Amedication reminder may be used for a single medication, a group ofmedications with same schedule, or several medications with differentschedules. Besides the specific shortcomings of each individual design,medication reminders suffer from the following common disadvantages:

-   (C1) User has to set the clock.-   (C2) User has to program the medication reminder for each scheduled    event.

Many prior art designs combine medication reminder with bulk medicationorganizer or dose-compartment medication organizer. Examples of priorart designs include: U.S. patent application Pub. No. 2004/0182873 and2001/0022758, and U.S. Pat. Nos. 6,131,765, 5,990,782, and 5,826,217.Such designs overcome some of the disadvantages of the bulk (A2 and A3)and dose-compartment medication organizers (B7 and B8), but theyincorporate the disadvantages of the medication reminder (C1 and C2).

A user can use a dose-compartment medication dispenser. Adose-compartment medication dispenser is similar to the above describeddose-compartment medication organizer, except using motors to align(rotate) the dose-compartment with the outlet. Examples of prior artdesigns include: U.S. patent application Pub. No. 2003/0127463 and2002/0118604, and U.S. Pat. Nos. 6,834,775, 5,159,581, and 4,573,606.Dose-compartment medication dispensers incorporate the disadvantages(B1) to (B6) of dose-compartment medication organizers and thedisadvantages (C1) and (C2) of medication reminders. They have furthercommon disadvantages:

-   (D1) Since now the order of dose compartments is tied to the    sequence of dispensing, loading the medication and programming the    scheduled events become even more complicated.-   (D2) Most of them can only handle simple schedules (e.g., three    times everyday).-   (D3) Even if some of them can handle complex schedules, programming    such schedules and loading the medications accordingly are very    complicated and tricky, hence, practically prohibitive.

A user can use a bulk medication dispenser. Examples of prior artdesigns include U.S. patent application Pub. No. 2003/0222090 and2002/0070227, U.S. Pat. Nos. 6,607,094 and 4,953,745. Bulk medicationdispensers store each type medication in a storage compartment, similarto bulk medication organizers, but they can dispense the unit-dosemedications according to scheduled events. Although bulk medicationdispensers offer several advantages over other groups, e.g., efficientstorage, easier loading and deleting, they suffer from the followingcommon disadvantages:

-   (E1) User has to set the clock.-   (E2) They typically require substantial user programming-   (E3) They require complex user-programming interfaces (some prior    art designs require a PC to program a bulk medication dispenser).-   (E4) User has to find appropriate storage compartment (original one    for a refill or empty one for new) to load the medication.-   (E5) User has to tell the system (through additional user    programming) which medication is stored in which compartment.

As explained above, all these prior art designs require manual effort,or programming effort, or both. Generally speaking, the designs with lowlevel of automation require low level of programming effort but highlevel of manual effort, the designs with high level of automationrequire low level of manual effort but high level of programming. Thisis a dilemma for the prior art designs. Both manual task and programmingnot only make prior art devices difficult to use, but also can causeerrors.

These prior art designs have overlooked a crucial fact, namely, themajority of medication users by far are elderly people, who are leastwilling and able to perform such manual and programming tasks. Even if adevice has some wonderful features, complicated manual operation or userprogramming could cause the users not to utilize these features, not toutilize them to their fullest capacity, or possibly to abandon it alltogether.

Furthermore, the designs that require user programming, especially thoserequire substantial or complex user programming, are not suitable forsome users, especially vision-impaired users. Some devices and designsare claimed to be suitable for vision-impaired users since audiblealarms and voice messages are used instead of visual displays. As longas these devices and designs require user programming and clock setting,they pose a severe and often prohibitive challenge to vision-impairedusers.

Methods have been developed or proposed in prior art to ease useroperations, but most of them merely shift the user operation burden toprofessionals.

A user can have his/her medications prepackaged and use a prepackagedmedication dispenser. A prepackaged medication dispenser dispensesunit-dose packages, each unit-dose package containing one or severalmedications to be taken at same time. This is similar to adose-compartment medication dispenser, except that the unit doses areprepackaged by medication provider, instead of being loaded by the user.Examples of prior art designs include: U.S. patent application Pub. No.2004/0158350 and 2003/0042167, U.S. Pat. Nos. 6,848,593, 5,221,024, and4,797,283. Although it relieves user from grouping and loading themedications, this method imposes most restrictions upon the users amongall prior art methods. Besides specific shortcomings of each individualdesign, this method suffers from the following common disadvantages:

-   (F1) All medications of a user have to come from a single provider    that prepackages them, or they are left out.-   (F2) Only the medications of same schedule can be prepackaged    (together).-   (F3) Practically, it is only suitable for long-term medications and    medications with regular and simple schedules (otherwise, packaging    instructions and programming are likely to be too complicated).-   (F4) Each specific design of dispenser can only work with one type    of package/magazine and vise versa.-   (F5) Each specific design of packages requires a specific packaging    line.-   (F6) A user of a particular prepackaged dispenser is usually stuck    with a specific provider (because of F4 and F5).-   (F7) Each type of package/magazine can only handle certain types of    medications.-   (F8) Each type of package/magazine is only suitable to a certain    amount of medications.-   (F9) Only certain types of medications are suitable for    pre-packaging.-   (F10) It is impossible to add a new medication (user has to discard    medications already packaged and reorder).-   (F11) It is impossible to change the sequence of the medications    (user has to discard medications already packaged and reorder).-   (F12) It is very difficult to delete a medication unless user can    identify it by appearance and discard them from every unit-dose    package.-   (F13) Cost is high due to service fees and wasted medications.

Generally speaking, any change in user's medication usually meansdiscarding all prepackaged medications and reorder, since any confusionor error may have devastating consequences.

U.S. patent application Pub. No. 2004/0133305 and 2002/0000917, and U.S.Pat. No. 5,408,443 suggested that medication providers, e.g.,pharmacies, provide a pre-programmed device (medication reminder plusstorage, or medication dispenser) with filled medication. Besidesspecific disadvantages of each individual design, this method suffersfrom the following common disadvantages:

-   (G1) It is subject to cross contamination and hygiene problems since    the devices will be passed to different users.-   (G2) User has to bring the device from and to the medication    provider for new medication, returning (when medication finishes),    and having it reprogrammed (if doctor has directed any change).-   (G3) It drastically changes the routines and increases the workload    of the medication provider.-   (G4) It generates additional service cost.-   (G5) It can only be used for prescription medications (no help for    non-prescription medications).

Also, remote administration of medication has been proposed. Examples ofprior art designs include: U.S. patent application Pub. No.2004/0210488, 2004/0172163, 2002/0147526, and 2002/0113077.

The basic idea of remote administration of medication is to let acaregiver (physician, nurse, or other qualified individual) to programthe scheduled events for a user via Internet on a dedicated server. Thededicated server in turn controls a medication dispenser at user'sresidence (remote-controlled dispenser, usually a prepackaged dispenser)via a dedicated telephone line or other communication means (cable orwireless). Some prior art designs further require a local PC to controlthe dispenser. Basically, the caregiver takes over the manual andprogramming burden from the user. Besides specific shortcomings of eachindividual design, remotely controlled medication systems have thefollowing common disadvantages:

-   (H1) They require large supporting system including infrastructure    and personnel, which in turn require considerable initiative and    investment.-   (H2) The supporting systems must keep all medical record of a user,    track and administrate all medications of the user.-   (H3) They require collaboration and coordination of many parties,    including the insurance company and other caregivers of the user.-   (H4) Once enrolled, a user is likely to be stuck with a system for a    long time since it is difficult to switch to another system.-   (H5) The Internet can hardly be secured completely, and computer    systems, especially large ones, can hardly avoid malfunction; hence,    the user is exposed to additional risks, such as stolen personal and    medical information, administration of a wrong medication, a wrong    dose, or a wrong time.-   (H6) The caregiver has to come to the user's home to load the    dispenser periodically or anytime there is a change in user's    medication.-   (H7) A high maintenance cost is charged to the user.

It has been proposed in prior art to use memory devices to storemachine-readable information. Examples of prior art designs include:U.S. patent application Pub. No. 2004/0039481, 2003/0099158,2002/0067270, 2002/0027507, and 2001/0028308, U.S. Pat. Nos. 6,611,733,6,529,446, 6,380,858, 6,335,907, 6,294,999, 6,259,654, 5,852,590,5,522,525, and 5,181,189 proposed similar ideas where memory strip, ICchip, or barcode that contains schedule and unit-dosage information wereattached to (or made on) the package of each medication. When thepackage is correctly mounted on the medication device, the memory strip,IC chip, or barcode are connected or aligned with a reader, so thestored information can be read and used to set the scheduled events.These designs have the following common disadvantages:

-   (I1) They require specially designed medication containers.-   (I2) The memory strip, IC chip and barcode have to be affixed on the    packages with accurate position and orientation.-   (I3) They require the specially designed medication containers be    accurately mounted on the device such that the memory strip, IC    chip, or barcode (hence the medication) are aligned with the reader    or a set of electrical leads connect with that of the device.

In addition, U.S. Pat. Nos. 6,335,907 and 5,181,189 in this grouprequire

-   (I4) each medication to use a device.

U.S. patent application Pub. No. 2004/0039481, 2003/0099158,2002/0067270, 2002/0027507, and 2001/0028308, U.S. Pat. Nos. 6,611,733,6,529,446, 6,380,858, 6,294,999, 6,259,654, 5,852,590, and 5,522,525 inthis group require

-   (I5) redundant components (memory readers and control units), each    for a medication.

When used with a remote sensing method, such as RF tags as suggested inthese prior art designs, multiple readers are

-   (I6) subject to interference.

U.S. Pat. Nos. 6,281,798, 6,119,892, 6,032,085, and 4,695,954 proposeddesigns with detachable card (smart card or magnetic card) that storedthe machine-readable information. The detachable card is inserted intothe proposed user devices that can read the information and set thescheduled events. Although these designs can handle multiplemedications, without providing a convenient method for user to load themedications into the devices, they require:

-   (I7) the device or a detachable storage to be filled by a pharmacy,    or-   (I8) additional user operation, additional components, and    additional controls.

In general, all these prior art designs with memory devices

-   (I9) have limited applications,-   (I10) restrictive configurations, and-   (I11) very little flexibility.

Furthermore, all these designs with memory devices

-   (I12) require users to set clock.

Finally, all of the prior art programmable devices and systems havethree common disadvantages:

-   (J1) The methods of user-request expression (loading, refilling,    modifying, deleting, taking emergency dose, etc) are too complicated    and complicated user-input interfaces are required.-   (J2) They do not provide guided user operations.-   (J3) They do not provide automatic medication-storage mapping.

In order to achieve certain level of automation, such as automaticdispensing, a mechanism is needed for the system to tie the medicationwith its storage. For definiteness, this mechanism will be calledmedication-storage mapping. When a user loads a medication to a priorart system, the user not only has to program the scheduled events butalso has to tell the system where the medication is stored throughadditional user programming, so that the system can establish themedication-storage mapping. This kind manual medication-storage mappingnot only is cumbersome but also can cause errors, prompting some priorart designs to require pharmacy to load the medications, or to useredundant components or devices, each handling one medication.

In conclusion, despite the improvements of the method and system formanaging and administering medications, many problems remain unsolved,or their solutions remain unsatisfactory. There is definitely a need fora method and system that substantially overcome the aforementioneddisadvantages of the prior-art designs and provide overall satisfactoryresults.

BRIEF SUMMARY OF THE INVENTION

The present invention is a method and control unit for medicationadministering devices. The first aspect of the present invention isautomatic programming of the scheduled events for medications. Hence theuser programming, the user-programming interface, and user programmingerrors are all eliminated. The second aspect is simple user-requestexpression. Hence both user input and user-input interface are extremelysimple. The third aspect is guided user operation. The system guides theuser to complete necessary operations corresponding to the userrequests. Hence user operations are significantly simplified. The forthaspect is automatic medication-storage mapping. While with easy loading,the system establishes medication-storage mapping automatically withoutany additional user effort. The fifth aspect is no clock setting. Henceclock-setting interface is eliminated and the user-input interface isfurther reduced. Prior art systems typically require the user to figureout a loading-scheduling plan, follow the plan to load the medications,program the scheduled events, and tell the system how the medicationsare stored (manual medication-storage mapping). The system of thepresent invention does the opposite: it figures out theloading-scheduling plan, guides the user to load the medications,programs the scheduled events, and establishes medication-storagemapping, all automatically. Each of the five aspects of the presentinvention overcomes a number of the aforementioned prior artdisadvantage. Each of them reduces or simplifies the physicalcomplexity, the components, and the user operations. Each of themreduces potential errors associated with the prior art designs.Combining these aspects together, the present invention overcomes allaforementioned disadvantages of the prior art designs, significantlysimplifies or reduces the complexity, the components, the potentialoperation errors of the prior art designs, and greatly simplifies theuser operations. The method and control unit of the present inventioncan be adopted to control all types of medication administering devices(existing and future developed), is very flexible (basically norestriction in configuration, dimension, or interconnection of thecomponents), and easy to use. Due to its high level of automation andease of use, vision-impaired users and other users that are excluded byprior art systems can easily use the system of the present invention.

The major objectives and advantages of the present invention are:

-   -   (1) To provide a method and control unit that satisfies        practically all needs for medication management and        administration.    -   (2) To provide a method and control unit that automatically        programs the scheduled events for each medication, hence        eliminates user programming, user-programming interface, and        user-programming error.    -   (3) To provide a method and control unit that automatically        tracks the scheduled events and takes appropriate actions.    -   (4) To provide a method and control unit that has a minimal        user-input interface and allows users to express requests with        very simple manners.    -   (5) To provide a method and control unit that guides the user to        complete all necessary user operations.    -   (6) To provide a method and control unit that automatically        establishes medication-storage mapping without any additional        user effort.    -   (7) To provide a method and control unit that does not require        clock setting and clock-setting interface.    -   (8) To provide a method and control unit that has a minimal        user-input interface, requires minimum and simple user        operations, and reduces the user-operation errors associated        with prior art designs.    -   (9) To provide a method and control unit that can be used by any        number of users, can control any number of devices, can handle        any number of medications, with any precise timings, any        different schedules, and any complex schedules.    -   (10) To provide a method and control unit that vision-impaired        users and other users that are excluded by prior art systems and        devices can easily use.    -   (11) To provide a method and control unit that is so easy to use        hence there is no longer a need for professional assistance or        having medications prepackaged.    -   (12) To provide a method and control unit that user are not        required to subscribe to any organization for managing their        medications and no large supporting system is needed.    -   (13) To provide a method and control unit that does not require        redundant components.    -   (14) To provide a method and control unit that can be adopted        for all types of medication administering devices.    -   (15) To provide a method and control unit that basically has no        restrictions on configuration, dimension, interconnection among        its components, and detailed design of the controlled device,        giving the device manufacturers maximum freedom in designing        their devices.    -   (16) To provide a method and control unit that does not require        medication providers to drastically change their routines,        equipments, or medication packages.    -   (17) To provide a method and control unit that allows users to        freely choose their medication providers and medication        administering devices.    -   (18) To provide a method and control unit that is of low cost to        users.    -   (19) To provide a method and control unit that overcomes all        aforementioned disadvantages of the prior art designs.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

In the drawings, closely related figures have the same number butdifferent alphabetic suffixes.

FIG. 1 is the block diagram of the major components of the control unitof the present invention.

FIG. 2 shows one example of the programming-information carrier:programming-information barcode.

FIG. 3 shows the block diagram of the processing unit.

FIG. 4A shows one exemplary application of the present invention: adose-compartment medication organizer with indicator.

FIG. 4B shows another exemplary application of the present invention: adose-compartment medication organizer with multiple LEDs, each for adose compartment.

FIG. 5A shows yet another exemplary application of the presentinvention: a bulk medication organizer with an indicator.

FIG. 5B shows yet another exemplary application of the presentinvention: a bulk medication organizer with multiple displays, each fora compartment.

FIG. 6 shows yet another exemplary application of the present invention:a dose-compartment medication dispenser.

FIG. 7A shows yet another exemplary application of the presentinvention: a bulk medication dispenser.

FIG. 7B shows yet another exemplary application of the presentinvention: a bulk medication dispenser with a common access door.

FIG. 8 shows yet another exemplary application of the present invention:a prepackaged medication dispenser.

FIG. 9 shows the system of present invention using both encoded andpreloaded usage information.

FIG. 10 summarizes operations of the system of the present invention.

FIG. 11 shows yet another exemplary application of the present invention(with an optional control button): a medication reminder.

FIG. 12 shows the system of present invention with multiple (differenttypes) programming-information reader and conventional controls.

DETAILED DESCRIPTION OF THE INVENTION

To best explain the fundamental idea of the present invention, the mostbasic form of the present invention will be described. It should not beconstrued in any way as limitation or restriction of the presentinvention.

Preferred Embodiment

Refer to FIG. 1 for the major components of the control unit of thepresent invention. The control unit comprises two major components, aprogramming-information reader 10 and a processing unit 20. Theprogramming-information reader 10 is capable of reading programminginformation encoded in machine-readable format according to an encodingprotocol. The programming information is stored in aprogramming-information carrier 100. The present invention uses varioustypes of programming information in various suitable situations. Typicalones include medication identifier, usage information, user identifier,and user requests, which can be selectively combined and stored in asingle programming-information carrier or stored separately. For clarityand simplicity, the preferred embodiment section mainly concerns twotypes of programming information unless otherwise stated. The first onecontains both medication identifier and usage information of amedication, and the second one contains only the medication identifier(to be used with preloaded usage information, as explained later). Otherexamples of programming information will be discussed in later sections.The control unit can be adopted to control any type of medicationadministering device 300, and all typical examples of such devices willbe given later. The medication administering device 300 will also bereferred as the controlled device. The control unit plus the controlleddevice will be referred as the medication administering system, orsimply the system.

The programming-information is considered as an external component, justlike human-readable usage information to prior art systems. The dashedboxes in FIG. 1 indicate that both programming-information carrier 100and the controlled device 300 are external components (to the controlunit). Medication provider (pharmacy, mail-order filler, drug ordietary-supplement manufacturer, etc.) or prescription generator(doctor) may provide the programming information. Standard templates orpreloaded usage information may also be used. All these types will beexplained in detail.

The two major components of the control unit described above are logicaldivisions rather than physical divisions of the control unit of thepresent invention. Physically, these two major components can beseparate components or integrated together. They can also be broken downto further granular components. The sub-components of the two majorcomponents may also be shared or selectively moved from one majorcomponent to another. These two major components (or some of theirsub-components) may even be integrated with the external components,namely, the programming-information carrier 100 or the controlled device300 (examples will be given later).

The arrows in FIG. 1 represent communication links among all components(internal and external). Any suitable communication means, wired orwireless, currently existing or developed in the future, can be used.There are basically no restrictions on configuration, dimension,interconnection, or detailed designs for each component. With suchflexibility, the makers of the system virtually can choose any type ofmedication administering device, with any configuration, dimension,interconnection, and detailed designs they like. They can even makemodules that contain part of the system to work with complementarymodules made by others. The flexibility is a major advantage of thepresent invention over the prior art designs.

In the following, the term “scan” means to use theprogramming-information reader to read the programming information,unless otherwise stated.

The first aspect of the present invention is automatic programming ofthe scheduled events. Programming information that contains usageinformation allows programming of the scheduled events for a medication.Of course, the programming information may contain directly thescheduled events. A scheduled event can be either one-time or recurring.A one-time scheduled event has a specified date and time andautomatically expires when the specified date and time passes. Recurringscheduled event occurs repeatedly according to a predetermined pattern(e.g., three times a day), and it can be viewed as multiple one-timescheduled events. The programming information may also be encrypted forinformation security. It may further contain information to indicate thetype of the encoding protocol and the format if more than one encodingprotocol or format are used. It may also contain a “signature” (e.g., amark or a special format) to distinct it from other information.

Instead of using a conventional user-programming interface (whichconsists of buttons, keypad, touch screen) to program the scheduledevents as with typical prior art designs, the user of the system of thepresent invention simply scans the programming information. Theprogramming-information reader 10 converts the encoded programminginformation into appropriate programming-information signals, andtransmits them to the processing unit 20. The programming-informationreader 10 can be active (i.e., actively scans programming information),passive (i.e., passively receives programming information transmitted bythe programming-information carrier), or both (e.g., prompts the carrierto transmit and then passively receives). The processing unit 20 decodesthe programming information from the programming-information signalsaccording to the encoding protocol, and programs the scheduled eventsautomatically using the programming information. The user programming,the user-programming interface, and the user programming errors are alleliminated. The processing unit 20 stores the scheduled events andgenerates control signals for each scheduled events. The control signalsare sent to the controlled device, which takes appropriate actions inresponse to the control signals.

The major difference between this aspect of the present invention andthe prior art designs with memory devices is that the present inventionhas basically no restriction on configuration, dimension, orinterconnection of the components basically no restrict inconfiguration, no redundant components are required, no restriction onthe number of the controlled devices or the medications, no restrictionon medication containers and their relations to the system, and norestrictions on the type of the memory media, the positions andorientations of the programming information carrier.

It should be emphasized that the machine-readable programminginformation of the present invention differs fundamentally from the“electronic prescription” proposed in prior art, although the physicalcarrier and reader, or even the stored information itself, may be thesame or similar in both cases. The distinction is how and for whatpurpose the information is used. The programming information of thepresent invention is used to automatically program the scheduled eventsand express user requests (explained later), while the electronicprescription of the prior art does not have the same function and is notused for the same purpose.

The proposed use of electronic prescription in prior art is forpharmacies, medication order filling facilities, and medicationpackagers, to fill a prescription order. For example, the U.S. Pat. No.6,871,783 proposed a prescription module that carries doctor'sprescription electronically. U.S. Pat. No. 5,883,370 proposed to storeprescription in barcode for use with “pharmacy vending machines”. Suchsystems use the “order information”, namely, the name and total amountof a medication. Although the usage information is included in theelectronic prescription, it is simply passed to the user inhuman-readable form, e.g., shown on a display or printed on the packagelabel.

The second aspect of the present invention is simple user-requestexpression. The present invention not only uses the (machine-readable)programming information to program the scheduled events, but also usesit for users to express user requests (e.g., loading medication,refilling medication, modifying regimen for medication, deletingmedication, taking medication, requesting user-compliance report, etc.)conforming to a user-request protocol where presenting the programminginformation to the programming-information reader in a predeterminedmanner indicates a specific user request. This method of user-requestexpression has not been suggested in the prior art and it hassignificant advantages: the entire user-input interface can be reducedto only a programming-information reader, and the users express userrequests in extremely simple and consistent manner.

Given the fundamental idea of the user-request expression of the presentinvention, there are countless choices for the user-request protocol.One exemplary user-request protocol will be used in all descriptions ofthe preferred embodiment section: a single scan of the programminginformation indicates the request for taking a scheduled or emergencydose of a medication, a double scan (two consecutive scans within apreset period of time) indicates the request for loading (includingrefilling or modifying) a medication, a triple scan indicates therequest for deleting a medication, and a quadruple scan indicates therequest for a user-compliance report, etc. Preferably, the systemproduces a beep or other type of indication for each successful scan.

The processing unit 20 is programmed to detect the user requestsaccording to the user-request protocol. The processing unit 20 onlyaccepts valid and applicable user requests and takes predeterminedactions according to the user requests. The processing unit 20 ignoresinvalid user requests (do not conform to the user-request protocol) andinapplicable (e.g., taking emergency dose or deleting a medication whichis not in the system) user requests. This kind of user-request protocolsis so easy to memorize, and a user can master it right away. However,since it is so simple and compact, it may be imprinted on the device foreasy reference. Alternatively, the system may display or announce theuser-request protocol to remind the user.

The prior art designs (including those utilizing machine-readableinformation) require the users to express user requests throughconventional user-input interfaces consisting of buttons, keypads, touchscreen, etc. No prior art design has such simple user-input interface asthe present invention (a programming-information reader only). No priorart design allows users to express their requests in such simple andconsistent way (scanning the programming information only). As a matterof fact, the prior art devices typically have user operation menus thata user has to learn and refer to, and they are usually too big to beimprinted on the device.

Simple user-input interface and simple user-request expression havesignificant implications. They not only reduce the physical complexityand components of the system, but also make the system muchuser-friendlier and easier to use. Furthermore, they reduce theoperation errors. Complex user-input interface and elaborateuser-request expressions are always accompanied with potential errors.With simple user-input interface and simple user-request expression, thepresent invention reduces potential error one step further.

It should be emphasized that using programming information to expressrequests sets the present invention apart from any prior art use ofmachine-readable information. In prior art use of machine-readableinformation, (1) the user is not given any choice; (2) scanning themachine-readable information only accomplishes one task, namely,conveying the encoded information to the system; (3) the system alwaysacts the same way in response to the same encoded information. Using theUniversal Product Code (UPC) as example, when a cashier scans the UPCbarcode of a product, there is no choice given to the cashier about whathe/she wants to do, the scan only conveys the encoded information(product identifier) to the system, and the system always fetches theprice for the product and charges the customer. With the presentinvention, (1) the user is given multiple choices about what he/shewants to do; (2) scanning the programming information accomplishes twotasks, namely, it not only conveys the encoded programming informationbut also conveys the user request to the system; and (3) the system actsdifferently according to different user requests even though the encodedprogramming information is the same.

Different user request may require different programming information. Ifa user request requires programming the scheduled events (e.g., loadingnew medication, refilling, or modifying regimen for an existingmedication), the programming information must contain the usageinformation (unless preloaded usage information is used, which will bedescribed later). If a request needs to specify a medication, theprogramming information must contain the medication identifier. Forother types of requests (e.g., taking a scheduled dose, requestinguser-compliance report, etc.) where neither usage information normedication identifier is required, the processing unit may be programmedto allow users to use any suitable programming information (e.g., anyactive programming information of the user, or programming informationcontains the user identifier) to make such requests. For the sake ofsimplicity, the description often simply states “scan/use theprogramming information” (for expressing a user request), which shouldbe interpreted as “scan/use the programming information that containsproper information for the user request”.

The third aspect of the present invention is the guided operation. Foreach user request, there are necessary operations that a user has tocomplete. For example, when user requests loading or deleting amedication, the user has to physically load the medication into, orremove the medication from the appropriate storage. Prior art systemsleave their users alone to complete the user operations, where usershave to identify the right medication, the right amount, and the rightstorage, etc. in order to complete these operations. The system of thepresent invention provides guidance to help the user to completenecessary operations corresponding to user requests. In addition tocontrol signals for the scheduled events, the processing unit 20 alsogenerates guiding signals corresponding to user requests. The guidingsignals are sent to the controlled device 300. The controlled devicetakes appropriate actions in response to the guiding signals. Theactions may include indicating the right storage, the right medication(identifier/name), and the right amount, etc., with a guiding means (oropening the access door of the right storage), to guide the user tocomplete the necessary operations. The guiding means generally refers toa device that can provide visual, audible, or tactile indication, or anycombination of them. It may comprise displays (e.g., LCD screen), LEDs,buzzers, speakers, or vibrators. Most of the existing or conceivedmedication administering devices are equipped with such indicators, andthe present invention can use them as the guiding means in addition totheir original functions. The guiding signals may be used to drive theguiding means directly or used as commands/trigger signals.

The guided user operations not only simplify the user operations, makingthe system of the present invention much user-friendlier and easier touse than any prior art design, but also reduce the potential errorassociated with the prior art designs (such as loading a medication to awrong storage, loading a wrong amount of medication, removing a wrongmedication, etc.).

The fourth aspect of the present invention is automaticmedication-storage mapping. Lacking a convenient medication-storagemapping, prior art designs require complicated manual operations,additional user programming, professional assistance, redundantcomponents or devices, additional controls, or combination of them. Thepresent invention achieves automatic medication-storage mapping byeither combining it with guided loading or using sensors to detect wherethe medication is loaded. The first approach is that while guiding theuser to load a medication to appropriate storage, the processing unitregisters the storage with the medication (or the scheduled events). Thesecond approach is that the user selects the storage to load amedication, the sensor detects the storage, and the processing unitregisters the storage with the medication (or the scheduled events).Either way, the medication-storage mapping is automatically establishedwithout any additional user effort. Automatic medication-storage mappingnot only overcomes the disadvantages of the prior art designs regardingthis aspect, making the system of the present invention much simpler,user-friendlier, and easier to use than any prior art design, but alsoreduces potential error (e.g., registering a wrong medication or a wrongstorage) associated with the prior art designs. The operation of thesystem of the present invention is described in the following.

When the user needs to load a medication (including refilling amedication, or modifying the regimen of an existing medication), he/shedouble scans the programming information, indicating request forloading. The processing unit firstly checks if the same medication hasalready existed in the system. There are three possible outcomes. Thefirst one is that the medication does not exist (a new medication). Thesecond one is that the medication exists and the programming informationremains unchanged (a simple refill). The third one is that themedication exists but the programming information has changed (a refillwith modified regimen or modifying regimen without refill). Theprocessing unit finds appropriate storage: empty storage for newmedication or the original storage for all other cases (simple refill,refill with modified regimen, and modifying regimen). The processingunit generates guiding signal (for loading, in this case) and sends itto the controlled device. The controlled device produces indication(e.g., indicating the appropriate storage compartment), or opens theaccess door (e.g., releasing an electromagnetically controlled latch, orusing stepper motor) of the appropriate storage compartment. The userloads the medication as guided by the system (except for modifyingregimen, no medication is actually loaded for that case). Of course, theprogramming information may carry a flag indicatingnew/refill/modifying. Anyway, user does not need to worry if he/shealready has this medication in the system, what he/she has to do indifferent cases, or which storage to load the medication, but simplyfollows the guidance of the system. Since refilling and modifying are sosimilar to loading new medication, only “loading” is used and describedin the following descriptions. The reader should keep in mind thatloading also includes the other two cases.

The prior art devices typically require the user to provide furtherinformation (e.g., indicating new or refill, indicating the storage)and/or load the medication into appropriate storage, or otherwise theprior art systems may incorrectly treat a refill as a new medication andcause double dose.

The processing unit uses the programming information to program thescheduled events for the medication and stores them, if necessary (asimple refill of a medication with recurring scheduled events does notneed to have the scheduled events re-programmed). The processing unitalso establishes medication-storage mapping for new medication.

When a scheduled event (for the user to take medication) occurs, theprocessing unit generates control signals and sends them to thecontrolled device. The actions of the controlled device in response tothe control signals may include: producing alarm, indicating themedication and unit dosage, indicating the storage compartment, tec. Thecontrol signals may be used to drive the appropriate sub-components ofthe controlled device or used as commands. The user scans theprogramming information once, indicating request to take the scheduledmedication, and takes it. The processing unit may record the actual timethat the user scans the programming information as user-compliance data.

Besides scheduled events, a user may request an emergency dose of aparticular medication by scanning the corresponding programminginformation once. The processing unit recognizes the request foremergency dose since it is off schedule. The processing unit and thecontrolled device take the similar actions as for a scheduled dose,except that the alarm does not go off. The processing unit may beconfigured to skip the next scheduled dose or delay (reschedule) theremaining doses accordingly (this can also be directed by theprogramming information or user request). The programming informationfor some medications may indicate that no emergency dose is allowed orit is limited to certain amount, and the processing unit programsaccordingly.

When the user needs to delete a medication (as directed by doctor),he/she triple scans corresponding programming information, indicatingrequest for deleting. The processing unit may generate guiding signals(for deleting, in this case) and sends them to the controlled device.Depending on its capability, the actions of the controlled device mayinclude: indicating the storage and/or opening the access door of thestorage to guide the user to remove the medication, or dumping the(deleted) medication.

The system may also include an output device for user-compliance report(and/or outputting other information). The user quadruple scans theprogramming information, indicating request for user-compliance report.The processing unit generates a user-compliance report based on thescheduled events and the recorded user-compliance data, and outputs itin human-readable (printed) or encoded form (similar to the programminginformation). In the latter case, the programming-information reader maydouble as programming-information writer and reproduce the programminginformation. Providing user-compliance report is also a convenient wayto inform or remind the caregiver how (starting date/time, schedule, andunit dose) and what medications the user is currently taking.

FIG. 3 shows the block diagram of the processing unit 20. The firstcharacteristic of the processing unit of the present invention is thatit interfaces with the programming-information reader rather than aconventional user-programming interface as for the typical prior artsystems. The processing unit is capable of decoding the programminginformation from the programming-information signals (from theprogramming-information reader) according to the encoding protocol, andautomatically programs the scheduled events id required. The secondcharacteristic of the processing unit of the present invention is thatit also detects the user requests from the programming-informationsignals according to the user-request protocol. The third characteristicof the control unit of the present invention is that in additional togenerating control signals for scheduled events, it generates guidingsignals to guide the user to complete the necessary operationscorresponding to the user request. The forth characteristic of theprocessing unit of the present invention is that it automaticallyestablishes medication-storage mapping without any additional usereffort. The processing unit comprises a processor 21, a memory unit 22,a clock 23, and a power unit 24.

The processor 21 is mainly responsible for performing theabove-described functions of the processing unit. It runs an embeddedfirmware that handles all functions of the processing unit.

The memory unit 22 may consist of both non-volatile (ROM and/orelectrically erasable) memory and RAM to store the embedded firmware,programming information, scheduled events, medication-storage mapping,and other static and dynamic data.

The clock 23 keeps system time. Although in principle any suitable clockmay be used, it is preferable that the user does not have to set theclock and the clock is not interrupted by power outage. It is often seenthat the clocks of many household electronic devices (e.g., TV, VCR,stereo, microwave oven, telephone, fax machine) are not set or not setcorrectly, especially after a power outage. But having the clock of amedication administering device set incorrectly or interrupted by poweroutage could have devastating consequences. The fifth characteristic ofthe processing unit is that no clock setting (by user) is required. Onechoice is to have the clock set by manufacturer before shipment and keepit running (a pre-set clock, like many battery-driven watches, clocks,computers, and other electronic devices), so that user no longer needsto set clock. An alternative is to use a radio-controlled clock, whichreceives radio signal of standard time and automatically adjusts itself,hence eliminating the need of setting the clock. As a third alternative,the present invention proposes the use of a “relative-time” clock. Arelative-time clock dose not necessarily keep the real time, but simplycounts the elapsed time since the power is turned on. The user waitsuntil it is time to take the first daily dose of a new medication (theuser may elect to take the medication together with some other existingmedications) to program the scheduled events (i.e., double scan theprogramming information). The processing unit uses that time asreference and programs the schedules events relative to it. In this way,the need of setting the clock is completely eliminated (not even by themanufacturer), and the clock starts working when the user starts thedevice.

Since there is no need to set the clock, the (user) clock-settinginterface is no longer needed. Eliminating the clock setting andclock-setting interface reduces the complexity and components, makingthe system of the present invention user-friendlier and easier to usethan any prior art system, and reduces the potential errors associatedwith the prior art designs (e.g., caused by incorrectly set orinterrupted clock).

The power unit 24 provides power to the processing unit 20. Depending onthe specific design, it may also provide power to theprogramming-information reader and/or the controlled device. The powerunit 24 may include a backup power unit (e.g., with rechargeablebatteries, photocells, capacitors) to keep the system running andmaintain critical data (if they are stored in RAM) when the system istemporarily out of power. The backup power unit may further include acritical backup power unit that only keeps the clock running andmaintains critical data as to last much longer (several months or evenseveral years) without external power.

Most of the sub-components of the processing unit 20 can be integratedinto an Application Specific Integrated Circuit (ASIC), or ageneral-purpose programmable microcontroller may be used to perform allor most of the functions of the processing unit.

The present invention can use almost all types of memory media to storethe programming information. The preferred types ofprogramming-information readers/carriers will be described in thefollowing.

One embodiment of the programming-information reader is a barcodescanner, and the corresponding programming-information carrier is abarcode. This special barcode will be called programming-informationbarcode, in order to distinct it from any other barcode, such as the UPCbarcode that identifies a product (manufacturer and product identifier).

Use pharmacy-filled prescription as an example: when a pharmacist fillsthe prescription for a user, the pharmacist enters into the pharmacy'scomputer system the medication identifier (name) and the usageinformation along with other relevant information, such as doctor'sinformation, user's information, insurance information, etc. There is nochange in pharmacist's routine and equipment. The pharmacy can use anycontainer or package suitable for the medication. Only the pharmacy'ssoftware takes an extra step: it encodes the medication identifier andthe usage information into a programming-information barcode formataccording to an encoding protocol and prints it on the medication label.The medication label includes all other information as usual, as well asthe programming-information barcode, as illustrated in FIG. 2. Thesoftware that generates the programming-information barcode can be anintegrated component of the pharmacy's software or a separate softwaremodule provided by a third party.

If the medication label requires another barcode, such as the UPCbarcode, the programming-information barcode may be marked, folded orprovided separately to avoid confusion. Since theprogramming-information barcode has a specific signature, there is noactual interference. No particular position or orientation is requiredfor the programming-information barcode, which does not even have toappear on the medication label or medication container, and can beprovided separately.

The user takes home the medication, uses the programming-informationbarcode to express user requests, and follows the guidance of the systemto complete the necessary user operations, as described previously.

Studies have shown that the error rate of barcode scanning is about 1 in10 million. That is much lower than the error rate of human input (witha keyboard or similar user-input interface), which is about 1 in 100.So, the present invention virtually eliminates the programming error.

It is sufficiently clear from the above description that theprogramming-information barcode of the present invention differsfundamentally from other barcodes currently used or proposed in priorart. The barcodes used in prior art are mainly for identificationpurposes, such as to identify a person (patient or caregiver), amedication (name, source, lot number, expiration date, etc.), orinternal use to identify an order, a storage unit, etc. For example, theFDA rules use of barcodes in the healthcare facilities to match thepatient with the prescribed medication for that patient. Although thebarcode on the package of unit-dose medication, which ensures the fiverights (right patient, right drug, right dose, right route, and righttime), contains unit dosage and time information, it is not used forprogramming medication administering devices or user-request expression,but for verifying whether the unit dose matches the medication recordfor the patient in the database. Of course, the present invention canextend the programming-information to incorporate further information(such as user identifier) for additional purposes, if deemed useful ornecessary.

Another embodiment of the programming-information reader is a magneticcard reader, and the corresponding programming-information carrier is amagnetic card (similar to a credit card reader and the credit cardpair). In this case a paper or plastic card with both human-readableinformation and a magnetic strip that encodes the programminginformation may be used instead of the medication label. The method ofuse is very similar to that of programming-information barcode.

Yet another embodiment of the programming-information reader is aradio-frequency (RF) tag receiver, and the correspondingprogramming-information reader is a RF tag. In this case, the paircommunicates wirelessly via radio waves. Preferably, the RF tag has alow transmission range, so that it can only be read in the proximity ofthe receiver.

Yet another embodiment of the programming-information reader is a smartcard reader, and the corresponding programming-information reader is asmart card. Smart card has embedded IC and memory. The IC of a smartcard may have sufficient processing power to do more than just providingmemory, e.g., taking some or even full functionality of the processingunit. In such case, the programming-information carrier (externalcomponent), the programming-information reader, and the part of, or theentire processing unit, are physically integrated in the smart card(detailed description of this embodiment will be given later).

In order to store large amount of programming information, e.g.,complicated programming information or with additional information, 2Dbarcodes can be used. Magnetic strip (with multiple tracks) and smartcard usually have large capacity, and are erasable and re-writable.Re-writable programming-information carriers allow the programminginformation to be modified. So, the programming information can beupdated and these carriers can be reused. Furthermore, new information,such as user-compliance information, can be added. When using are-writable programming-information carrier, such as magnetic card orsmart card, the output device and the programming-information reader canbe combined to form a machine input/output interface. This machineinput/output interface not only reads the programming information fromthe programming-information carrier but also writes the (encoded)user-compliance report (and perhaps other information) back to it.

The method and control unit of the present invention can be adopted tocontrol any type of medication administering system or device, and alltypical types of such devices, as well as the corresponding methods ofguided user operations and automatic medication-storage mapping, will bedescribed in the following.

One example of the controlled device is a dose-compartment medicationorganizer with an indicator. In this case the system works as adose-compartment medication organizer with auto-programming medicationreminder. FIG. 4A shows the top view of the system. In this exemplaryconfiguration, the programming-information reader (on the sidewall ofthe device, not seen in this top-view figure), the processing unit, andthe controlled device are all integrated into one physical unit. Thedose compartments are labeled from 1 to 12.

As mentioned previously, it is difficult to load medications to, add newmedication, or delete medications from the prior art dose-compartmentmedication organizers and dispensers. That can be demonstrated by asimple example. Suppose that a user has to take two tablets ofmedication A every two hours, one tablet of medication B every threehours, and one tablet of medication C every five hours. With the priorart systems, the user has to figure out the following loading-schedulingplan, load the medications, and program the scheduled events accordingly(notice that the time intervals are not uniform): Compartment numberUnit dosage schedule 2A, 1B, 1C 0 hours 1 2A 2 hours 2 1B 3 hours 3 2A 4hours 4 1C 5 hours 5 2A, 1B 6 hours 6 2A 8 hours 7 1B 9 hours 8 2A, 1C10 hours 9 2A, 1B 12 hours 10 2A 14 hours 11 1B, 1C 15 hours 12 2A 16hours

This loading-scheduling plan is oversimplified, since it ignores theconstraints of total daily dosage of each medication, and the userprobably does not want night schedules. Figuring out even such anoversimplified loading-scheduling plan requires some skill and brainworkfrom the user, and it can be quite difficult or even prohibitive forsome users, especially vision-impaired users. Loading subsequent roundsis even more difficult since the user has to remember the previous roundin order to continue. Due to this severe problem, the prior artdose-compartment medication organizers and dispensers practically areused to manage medications with extremely simple schedules, such as afew times everyday with uniform intervals.

The present invention provides a solution to this problem: guided useroperation. With the present invention, the user simply double scans theprogramming information of all medications one after another within apredetermined period of time (e.g., one minute), indicating request forloading several medications. The processing unit automatically figuresout the loading-scheduling plan and guides the user to load themedications. For example, the display 310 may show a message like this:2 A: 1, 3, 5, 6, 8, 9, 10, 12; 1 B: 2, 5, 7, 9, 11; 1 C: 4, 8, 11. Thismeans to load 2 tablets of medication A into dose compartment 1, 3, 5,6, 8, 9, 10, and 12, and so on. In the case where each dose compartmenthas its own indicator (LED), the message may simply be: 2A, and the LEDsof compartment 1, 3, 5, 6, 8, 9, 10, 12 are flashing. This means to load2 tablets of medication A into every dose compartment with flashing LED.When the user finished loading medication A, he/she scans theprogramming information (can be any of them) and the processing unitguides the user to load other medications. Alternatively, the processingunit may be configured to guide the user to load the dose compartments(instead of medications) in sequence. The display may show a messagelike: 1: 2A, 2: 1B, 3: 2A, etc. in sequence, just as the aboveloading/schedule plan. In the case where dose compartments have theirown LED indicators, the display shows 2A and the LED of dose compartment1 is flashing, and so on. There are many other similar ways to guide theuser to load the medications.

While guiding the user to load the medication, the processing unit alsoestablishes the medication-storage mapping automatically without anyadditional user effort. For dose compartment medication organizer(dose-compartment medication dispenser or pre-packaged medicationorganizer/dispenser), the processing unit actually registers scheduledevents (instead of medication) with the storage (dose compartments). Theprocessing unit can easily handle total daily dosage and skip nightschedules. Loading subsequent rounds is just as easy since theprocessing unit remembers the previous round and guides the user tocontinue.

This example manifests the fundamental difference between the prior artsystems and the system of the present invention. The prior art systemstell their user: “Figure out the loading-scheduling plan, follow yourplan to load the medications, and tell me (enter through userprogramming interface) the scheduled events and the medication-storagemapping”. While the system of the present invention does the opposite:“I have figured out the loading-scheduling plan for you, follow myguidance to load the medications, and I will take care of the scheduledevents and the medication-storage mapping”.

When the user needs to load a new medication to an already loadedsystem, he/she double scans the corresponding programming information,indicating request for loading. If the schedule of the new medication iscompatible with those of the existing medications, the processing unitwill guide the user to load the new medication into the appropriate dosecompartments. In the case that the schedule of the new medication is notcompatible with those of existing medications, the processing unit willguide the user to reload all medications. Since the system of thepresent invention provides guided user operations, the reload is nolonger a daunting task.

When a scheduled event occurs, the display 310 of the indicatorindicates the corresponding dose-compartment number (e.g.,dose-compartment #8 as shown in FIG. 4A), and the alarm 320 sounds. Theuser scans the programming information once (which stops the alarm) andtakes the medication. The processing unit records the actual time whenthe programming information is scanned as user-compliance data. Ofcause, each dose-compartment may have its own LED, as shown in FIG. 4B.

The user uses the programming information for all other requests,conforming to the user-request protocol described previously. Foremergency dose, the actions of the processing unit and the controlleddevice are very similar to those for scheduled dose, except that thealarm does not go off. For this example, the next scheduled dose isautomatically skipped (the user has already consumed it). For deleting amedication, the processing unit deletes the scheduled events for thatmedication (if they exists alone), and the indicator indicates all dosecompartments containing that medication to guide the user to removethem.

Yet another example of the controlled device is similar to the aboveone, except that the dose compartment medication organizer has multiplemagazines, each having multiple dose compartments in turn. Thisembodiment is suitable for medications with very different or verycomplex schedules. Of course, once can always use one magazine for eachmedication, but such arrangement results inefficient storage. On theother hand, it is impractical to ask a user to figure out an optimalloading-scheduling plan that groups the medications into magazines toachieve the most efficient storage and programming. With the presentinvention, the processing unit automatically groups the medication withcompatible schedules into the same magazine and figure out theloading-scheduling plan for each magazine. All operations are verysimilar to those of the example immediately above except magazine number(identifier) should also be included in programming. Since a newmedication with incompatible schedule can always be added with a newmagazine, the existing medications no longer have to be reloaded.

Yet another example of the controlled device is a bulk medicationorganizer with an indicator. In this case the system works as a bulkmedication organizer with auto-programming medication reminder, as shownin FIG. 5A. In this exemplary configuration, the programming-informationreader, the processing unit, and the controlled device are allintegrated into a console.

When the user needs to load a medication, he/she double scans theprogramming information, indicating request for loading. The processingunit finds appropriate compartment and the corresponding compartmentnumber is displayed on 310 and/or the corresponding access door opens,and the user loads the medication into the compartment. The processingunit programs the scheduled events if necessary. The medication-storagemapping is automatically completed without any additional user effort.An alternative method for automatic medication-storage mapping is toinstall a sensor (a simple micro switch will do) on each access door.Instead of guided by the system, the user chooses appropriatecompartment and loads the medication. The sensor detects the compartment(the access door has been opened and closed) and the processing unitestablishes the medication-storage mapping. The user may optionallytransfer the human-readable medication label to the correspondingcompartment for easy visual comprehension, as depicted in FIG. 5A.

When a scheduled event occurs, the display 310 shows the storagecompartment number and the unit dosage (e.g., 3 tablets from compartmentnumber 2, as shown in FIG. 5A) and the alarm 320 sounds. The user scansthe programming information once (the access door of compartment 2 mayopen) and takes the medication. The processing unit records the actualtime when the programming information is scanned as user-compliancedata.

The user scans the corresponding programming information for requestingan emergency dose of a medication. The actions of the processing unitand the controlled device are similar to those for scheduled dose,except that the alarm does not go off. The user triple scans theprogramming information for deleting a medication, the correspondingcompartment number is displayed and/or the access door of thecorresponding compartment opens, the user empties that compartment, andthe processing unit deletes the corresponding scheduled events.

Yet another example of the controlled device is a bulk medicationorganizer with multiple displays 310, each for a compartment, as shownin FIG. 5B. This case is very similar to the example immediately above,except the displays no longer need to display the compartment number.

Yet another example of the controlled device is a dose-compartmentmedication dispenser with an alarm. In this case, the system works as anauto-programming dose-compartment medication dispenser. In thisexemplary configuration, the programming-information reader, theprocessing unit, and the controlled device are integrated into onephysical unit, as depicted in FIG. 6. All operations are similar tothose of the dose-compartment medication organizer, except the scheduledand emergency dose are dispensed from the outlet 330.

Yet another example of the controlled device is similar to the above,but the dose-compartment medication dispenser has multiple magazines tohandle medications with very different and complex schedules. For thisembodiment, both the magazine and dose compartment number are displayed.All operations are similar to those of the above example.

Yet another example of the controlled device is a bulk medicationdispenser. In this case the system works as an auto-programming bulkmedication dispenser. In this exemplary configuration theprogramming-information reader, processing unit, and the controlleddevice are integrated into one physical unit. Each storage compartmentmay have its own access door (labeled 1 to 4) as depicted in FIG. 7A, orthey share a common access door (depicted in FIG. 7B) that can beselectively docked (automatically controlled by the processing unit) toa storage compartment inside the device. For this embodiment theprogramming information must include the medication identifier (name).This embodiment is fully automatic, yet programming free.

When user needs to load a medication, he/she double scans theprogramming information, indicating request for loading. The processingunit selects the appropriate compartment. The number of the selected thecompartment is displayed on 310, and/or the corresponding access dooropens. For the configuration in FIG. 7B, the processing unit docks thecommon access door with the selected compartment, and the common accessdoor may open. The user loads the medication as guided by the system.For either configuration, the medication-storage mapping isautomatically established without additional user effort. The processingunit programs the scheduled events if necessary. All operations aresimilar to those of bulk medication organizer, except that the scheduledand emergency doses are automatically dispensed and the deletedmedications are automatically dumped.

Yet another example of the controlled device is a prepackaged medicationdispenser with an alarm, as shown in FIG. 8. In this case, the systemworks as an auto-programming prepackaged medication dispenser. In thisexemplary configuration the programming-information reader, processingunit, and the controlled device are integrated into one physical unit.Except the medications are prepackaged (unit-dose packages are dispensedthrough outlet 330), the operations are similar to those ofdose-compartment medication dispenser.

Yet another example of the controlled device is similar to the above,but the prepackaged medication dispenser has multiple magazines tohandle medications with very different and complex schedules, orprepackaged medications from different providers. When the user needs toadd a magazine, he/she double scans the programming informationassociated with the magazine, indicating request for loading. Theprocessing unit selects and indicates an available (empty) mounting rackto guide the user to mount the magazine. The medication-storage mappingis automatically established without any additional user effort. Theuser uses programming information for all other requests, conforming tothe user-request protocol described previously. For emergency dose, thesystem dispenses a unit dose from the appropriate magazine. Fordeletion, the system deletes the corresponding scheduled events andindicates the magazine to guide the user to remove it. Of course,sensors (such as micro switches) may be used to detect which mountingrack a magazine has been mounted to or removed from, allowing thecontrol unit to establish medication-storage mapping automatically.

With automatic programming and guided user operations, the system of thepresent invention is so easy to use and there is no genuine need for auser to have medications prepackaged. These examples of prepackageddispenser simply illustrate that the present invention can be applied toall types of devices, simplify their structures (user-input interface),and improve their usability.

Yet another example of the controlled device is a modem or othercommunication device that can communicate with a number of remotedevices. The desired functions for the communication device may include:sending voice or text message for each scheduled event to remind theuser to take medication, reporting incompliance event, or any otherproblem, or that the inventory of a medication is below a predeterminedthreshold, to designated person. The designated phone numbers may beencoded in the programming information and read into the system when themedication is added. In this case the programming-information reader,the programming processing unit, and the controlled device may beintegrated into one physical unit. When a medication is finished ordeleted, the processing unit deletes the corresponding scheduled eventsand the designated phone number.

Yet another example of the controlled device is a PC. The control unitcommunicates with the PC through a cable or wirelessly (RF, infrared,etc), and the PC may in turn control other devices, or communicate withremote computers through Internet. A special application runs on the PCtakes appropriate actions in response to the signals that the controlunit transmits.

The last two embodiments may be configured to have the capability ofdownloading programming information from the remote device (or computer)to the local device. This is especially useful when doctor changes themedication regimen for the user. This differs from the remote-controlleddispensers of the prior art in that the scheduled events are programmedlocally and automatically as opposed to being programmed remotely and byhealthcare professionals. Furthermore, the communication device needs tobe connected and communication channel needs to be setup only whendownloading the programming information, as opposed to constantlyconnected and setup for receiving control signals as required by theprior art remote-controlled methods.

The alarm in the above descriptions may be replaced (or complemented)with a visual indicator (e.g., LED) or a vibrator to produce visual orvibration alarm. Similarly, the visual display may be replaced (orcomplimented) with a speaker, which announces pre-recorded orsynthesized voice messages. Examples include: “please take three tabletsof medicine xyz”, “please take the medication in dose-compartment numbereight of magazine number two”, “please load medication into/removemedication from compartment three”, and “please load two medication A,one medication B, and one medication C into dose compartment numbereight of magazine number one”.

As an alternative to the method described above, the processing unit mayhave preloaded usage information with medication identifier for commonmedications. For definiteness, these two methods will be referred as themethod of the encoded usage information and the method of preloadedusage information. With preloaded usage information, the programminginformation only needs to contain a medication identifier. One exampleis to use the manufacturer and product identifier encoded in the UPCbarcode of a medication as the medication identifier. Another example isto use the National Drug Code (NDC) of a medication as the medicationidentifier (NDC barcode will be available on medication packages in thefuture).

The user scans the programming information that contains the medicationidentifier (e.g., UPC barcode or NDC barcode) to express user requests,conforming to user-request protocol described previously, and theprogramming-information reader reads and converts it into appropriateprogramming-information signals. The processing unit decodes themedication identifier from the programming-information signals. Ifnecessary (programming the scheduled events is required), the processingunit searches the preloaded usage information with matching medicationidentifier and uses the corresponding preloaded usage information toprogram the scheduled events.

Similar to the encoded usage information, the preloaded usageinformation may contain directly the scheduled events. In that case,programming and deleting the scheduled events simply means activatingand deactivating them, respectively. The method of preloaded usageinformation is particularly suitable for non-prescription medications(OTC, dietary supplements, etc.). If NDC or other unique medicationidentifier is used, each preloaded usage information maps to a singlemedication identifier. If UPC or other non-unique medication identifieris used, each preloaded usage information maps to multiple medicationidentifiers (they all identify the same medication). The processing unitcan be easily programmed to accept multiple types of medicationidentifiers. Therefore, the method of preloaded usage information of thepresent invention is very flexible.

The method of preloaded usage information can be used separately or inconjunction with that of encoded usage information. Actually, the methodof encoded usage information and preloaded usage information representtwo extremes. In the most general case, the programming information mayhave entire or part of the information, and the preloaded informationmay contain entire or part of the information. The processing unitselectively uses them to complete the user request, according to apredetermined rule (e.g., the encoded information has precedence). FIG.9 shows the block diagram of the system of the present invention withthe general method.

The processing unit may also have preloaded medication-interactioninformation for common medications (especially suitable for the methodwith preloaded usage information). When the user loads a new medication,the processing unit checks the new medication against the existing onesfor potential interactions, and warns the user (e.g., sounds alarm,display warning message), or even refuses to load the new medication, ifinteractions exist. Of course, such interaction information may alsocome with the programming information for medications having knownstrong interaction, provided a large capacity carrier is used. Thisprovides an additional layer of safeguard.

U.S. Pat. Nos. 5,088,056, 4,970,669, 4,942,544, 4,837,719, 4,831,562,and 4,682,299 proposed medication reminders with preloaded scheduleinformation for common medications, but these prior art designs allrequire a piece of code that contains the starting memory address of theschedule information of a medication in order to retrieve it. Thismethod is quite cumbersome, because it requires that the medicationmanufacturers and medication providers know how the device manufacturerstores the schedule information for each medication in order to be ableto provided the memory address code. Unless the medication provider isalso the device manufacturer, this prior art method calls for anorganization similar to the Uniform Code Council (UCC, in charge of UPC)to coordinate with the medication providers and the device manufactures.UCC only needs to assign unique manufacturer identifier to eachmanufacturer (which in turn assigns product identifier and makes up theUPC for each product it produces), this organization has to assignunique memory address to each medication. Furthermore, it would be verydifficult to update the preloaded scheduled events, add new ones, orchange the design, since that would likely change the memory addresses.

The present invention (with preloaded usage information) does not haveany of these problems. There is no need for medication providers toprovide any extra code, since the UPC barcodes are already provided onthe packages for almost all medications (NDC barcodes are coming). Thepreloaded usage information can be updated and the new ones can be addedfreely, since the matching is based on the medication identifier asopposed to the memory address. Furthermore, scanning the medicationidentifier of the present invention also accomplishes the user-requestexpression. All other operations with the method of preloaded usageinformation are almost identical to those with the method of encodedusage information.

The operation of the system of the present invention is summarized inFIG. 10. The user expresses desired request by presenting theprogramming information to the programming-information reader in apredetermined manner, conforming to the user-request protocol. Theprocessing unit detects and determines the user request according to theuser-request protocol. The processing unit takes predetermined actionsaccording to the user requests. The processing unit also decodes theprogramming information according to the encoding protocol.

For loading (including refilling and modifying), the processing unitprograms the scheduled events selectively using the encoded informationand preloaded information, if required (for new medication or new usageinformation). The processing unit may further generate guiding signals(for loading, in this case). The actions of the controlled device inresponse to the guiding signals may include indicating the storage,indicating the medication, indicating the amount of medication, andopening the appropriate access door, to guide the user to load themedication. The processing unit may further establish themedication-storage mapping automatically.

For deleting a medication, the processing unit deletes the scheduledevents for the medication and the medication-storage mapping (ifapplicable). The processing unit may further generate guiding signals(for deleting, in this case). The actions of the controlled device inresponse to the guiding signals may include indicating the storage,indicating the medication, indicating the amount of medication, andopening the appropriate access door, to guide the user to remove themedication, or dumping the deleted medication.

For each scheduled event, the processing unit generates control signals.The actions of the controlled device in response to the control signalsmay include: producing (visual, audible, tactile) alarm, indicating themedication identifier (name), indicating the unit dosage, indicating thestorage, dispensing the medication.

For emergency dose, the actions of the processing unit and thecontrolled device are similar to those for scheduled dose, except thatthe alarm does not go off. The processing unit may be configured to skipthe next scheduled dose or delay the remaining doses.

If the user requests a user-compliance report, the control unitgenerates one based on the scheduled events and the recordeduser-compliance data (some type of indication of medicationconsumption). Other desired functions may be included, and thecorresponding operations generally follow the same pattern. The systemmay further comprise an output device for user-compliance report orother information. If a rewritable memory media is used, theprogramming-information reader may be combined with the output device(which may be called as the programming-information writer).

Differing from prior art use of machine-readable information where themachine-readable information is used only for one task (users are notgiven choice to make request), in the present invention the programminginformation is used not only for uses to express user requests but alsofor the processing unit to complete various types of user requests. Forexample, programming the scheduled events, dispensing emergency dose,and deleting medication all require using entire or part of theprogramming information. After loading the medication, the user shouldkeep the programming-information carrier for later use. Of course, othercontrols may be used as alternative ways for user-request expression(explained later). It should be emphasized that the present inventiondoes not require the programming information carrier always be insertedinto, or accurately aligned, or in stringent contact with any othercomponent of the system. Nor is the programming-information carrier tobe affixed to the medication package with precise location andorientation. In fact, it can be carried and kept separately from thesystem and medication. This kind flexibility is one of the advantages ofthe present invention over the prior art designs.

From the above descriptions, it is clearly seen that the system ofpresent invention automatically programs the scheduled events, has thesimplest user-input interface (programming-information reader), allowsusers to express user requests with extremely simple manners (scanningprogramming information), incorporates guided user operations,establishes medication-storage mapping automatically, and requires noclock setting. The system of the present invention is much easier andmore intuitive to use than any prior art system, hence, it can be usedby a much broader range of users. To further assist vision-impairedusers, physical confinements or marks recognizable by touch can be addedon the programming-information carrier and the programming-informationreader to assist their alignment, so that a vision-impaired user canscan the programming-information easily. Braille or other symbols mayalso be provided instead of, or in addition to normal text onprogramming-information carriers and the devices. Furthermore, to guidethe vision-impaired users to load, take, or delete medication, tactileindicators (e.g., small vibrators) may be added to each storagecompartment or container, and a speaker may be used instead of, or inaddition to a visual display.

Alternative Embodiments

It should be understood that the preferred embodiments described in thepreceding section serve only as examples. Based on the fundamental ideaand the spirit of the present invention, various alternative embodimentscan be readily designed.

In the preferred embodiment section, it is described that theprogramming information contains the usage information (or scheduledevents) and/or medication identifier. Obviously, additional informationcan be added for more detailed programming or for other enhancement. Forexample, the medication's expiration date may be included, and thesystem later warns the user of expired medication or takes otheractions, such as deleting the scheduled events and dumping the expiredmedication. The total amount of each loaded batch of medication may alsobe included in the programming information, so that the system can trackthe consumption of that medication and reminds the user to refill whenthe inventory is below a predetermined threshold. Of course, sensors maybe employed to detect the actual inventory of each medication. Theprogramming information may also contain a remind date/time forrefilling so that it can be programmed to remind the user. If themedication inventories are tracked, the processing unit may beprogrammed to delete the recurring schedule event of a medication whenthe medication is finished.

Additional (secondary) usage information for a medication, such as“taking plenty of water” or “taking before/with/after a meal”, can alsobe included in the programming information. The system may display orbroadcast such special instructions when the user takes the medication.The programming information may also include the type of the medication(e.g., blood-pressure control, antibiotics, cholesterol control, etc.)to inform the user. The programming information may even include animage of the medication to help user to identify it (for example, whendeleting a medication from a dose-compartment medicationorganizer/dispenser).

The programming information may also include tolerance in schedule (e.g.plus/minus 1 hour), unit dosage (e.g. plus/minus 1 tablet), and totaldaily dose (e.g. plus/minus 1 unit dose), so that the processing unitmay program (group) several medications for the user to take together(within their tolerances). The programming information may indicate amedication as “take as needed”. For such medication, the processing unitonly programs the unit dosage without the schedules, and the userrequests it just as requesting an emergency dose.

In the preferred embodiment section, several (preferred) embodiments ofthe programming-information carrier/reader pair are described:barcode/barcode scanner, magnetic card/magnetic card reader, RF tag/RFtag receiver, smart card/smart card reader. Additional examples forprogramming-information carriers may include diskettes, portable harddisks, flash memory, CDs, magnetic tapes (cassettes), optical(holographic) memory devices, biologic memory devices, etc (withcorresponding readers). Any suitable technology and device, presentlyexisting or developed in the future, may be used, as long as it iscapable of carrying and allowing the recovery of the programminginformation. Unusual carrier/reader pairs include image/digital camera,music box/microphone, where the pixels of the image and the tones of themusic encode the programming information. The communication between thepair (carrier and reader) can be electrical/electronic (plugged),optical/infrared (e.g., like a television remote control), radio,mechanical (e.g., vibration with specific patterns), sound (includinginfrasound and ultrasound). The programming-information carrier/readerpair may be integrated, for example, a memory device that outputsprogramming-information signals directly to the processing unit.

In the preferred embodiment section, it is described that theprogramming information is machine-readable. That does not excludeprogramming information that is also human-readable orhuman-comprehensible. For example, ordinary text medication label couldbe used as programming-information carrier if theprogramming-information reader is a scanner supported by acharacter-recognition system (implemented in the processing unit).Another example is a recording device (programming-information carrier)that carries recorded human-voice information (programming information)and a sound-receiving device (programming-information reader) such as amicrophone, supported by a human-voice recognition system. With thisembodiment, even a person that dictates the human-readable usageinformation (the programming information) plays the role of aprogramming-information carrier. Notice that even human-comprehensibleprogramming-information is considered “encoded” since it must follow apredetermined format (encoding protocol) in order to be interpretedcorrectly. Furthermore, encoding usually reduces memory space.

In the preferred embodiment section, the programming information isdescribed as one piece, e.g., a whole barcode. It is possible to divideit into more granular forms. For example, one piece for time/schedule,e.g., twice a day, one piece for unit dosage, e.g., three tablets, eachwith a special “signature” indicating its type.

In the preferred embodiment section, it is described that theprogramming information comes with the medication. Some medications (inparticular OCT and dietary supplements) with standard schedules anddosages can use pre-made templates. For example, the user can use alabel with both printed text “twice a day with one tablet” and aprogramming-information barcode encoded with the same information toprogram the scheduled events for a suitable medication. A user can alsocombine several pre-made granular templates, e.g., one encoded with“8:00 AM”, one encoded with “two tablets”, to make up a desiredprogramming information. Pre-made template is particularly helpful ifthe medication provider (pharmacy, mail-order, manufacturer, etc.) doesnot provide the programming information. A booklet of various pre-made(granular) templates may be provided with a medication administeringdevice (that incorporates the present invention), so that the user canmake up almost any regular (not too complicated) programminginformation. For some embodiments, medication identifier is notrequired, pre-made templates are sufficient. The control unit simplyregisters and refers medications as A, B, C, D, etc. Otherwise, pre-madetemplates can be used with another piece of programming information thatcontains the medication identifier, such as UPC or NDC. A booklet ofpre-made templates that contains common medication identifiers may alsobe provided for use with preloaded usage information.

Programming information may also be transmitted remotely via electronicmeans that are commonly available, e.g., transmitting aprogramming-information barcode via facsimile, or through Internet,e.g., attaching a programming-information barcode file to email.Programming information, especially pre-made templates, can also beprovided (by medication manufacturers, healthcare facilities, orqualified organizations) on web site for user to download. Again, remotetransmission of programming information differs fundamentally from theremote control methods of prior art. Here, the scheduled events areprogrammed locally and automatically, and the remote communication isonly needed when downloading the programming information.

In the preferred embodiment section, it is described that for Rxmedications the programming-information is provided by theprescription-filling facility. The process may start from theprescription generator, e.g., doctors in clinics and hospitals. When adoctor prescribes a medication for a user, the doctor's computergenerates the programming information (with additional information ifnecessary) and loads it into a programming-information carrier. Theprogramming information may be used by the prescription-filling facilityto fill the prescription (total quantity of medication must beincluded).

Studies have shown that miscommunication between doctors andprescription-filling facilities contributes a significant percentage tothe total prescription error. Using programming-information carrierthrough the entire process, from prescribing the medication toprogramming the user device, the present invention virtually eliminatesall potential errors that exist for the prior art methods.

In the preferred embodiment section, it is described that eachmedication has a programming-information carrier that carries theprogramming information for that medication. In fact, it is possible touse a single programming-information carrier for multiple medications.In particular, a reusable form of such carrier is a re-writable card(e.g., magnetic card or smart card) that contains programminginformation of all medication that a user is currently taking, or evencontains history information, as long as the storage allows it and suchinformation is deemed useful or necessary. The user carries this cardwhen he/she sees a doctor. The doctor can retrieve or update theinformation, such as obtaining user-compliance report, modifying theregimen, prescribing new medication, or deleting a medication. Eachmedication in the card may have a pharmacy flag and a user flag. Thedoctor's computer sets the flags to indicate a new medication, a refill,a modification, or a deletion. The pharmacy scans the card to retrieveorder information, fills the order, and updates the pharmacy flag toindicate the prescription has been filled. The user scans the card onthe user device to program the scheduled events, and the processing unitupdates the user flag to indicate the operation has been taken, e.g.,medication has been loaded or deleted. This “one card” will considerablysimplify the life of the users and reduce potential errors that exist inthe current process.

With the one card system, it is preferable that the system displays (orannounces, for vision-impaired users) all medications currently in thesystem, and allows the user to select a medication and make desiredrequest. The card may include other information, such as the next doctorappointment, which can also be programmed (as a scheduled event) toremind the user. Obviously, this one card system of the presentinvention is advantageous than the prior art electronic prescription,since it is used not only for filling the prescription, but also forprogramming the scheduled events and user-request expression.

In the preferred embodiment section, one exemplary user-request protocolis used where the number of scanning the programming information is usedto identify a request. The programming-information reader may beconfigured to scan repeatedly with a predetermined interval and thesystem beeps (or produces other indication) for each successful scan. Inthat way, when the user hears the desired number of beeps, he/she takesaway the programming-information carrier to indicate a selection. Orbetter yet, the system displays or announces applicable user requests,such as “taking” (medication), “loading”, “deleting”, and “reporting”.When the desired user request is being displayed or announced, the usertakes away the programming information to indicate a selection. Besidesthese exemplary user-request protocols, there are countless ways foruser to express requests using the programming information. For example,the time duration of scanning the programming information may be used toidentify the user requests, such as one second for taking a scheduledmedication or requesting an emergency dose, two seconds forloading/refilling/modifying, three seconds for deleting, and fourseconds for requesting a user-compliance report. Preferably, a signalcorresponding to the preset time duration for each operation isproduced, for example, one beep at the end of every second. Oralternatively, scanning programming information of a medication causesthe system to display or announce all applicable requests sequentially(and repeatedly), and the user stops scanning (takes away theprogramming-information carrier) when the desired request is beingdisplayed or announced.

In addition, multiple pieces of programming-information may be providedfor each medication, each being used for a specific request. Forexample, one is encoded with a flag indicating loading (includingrefilling and modifying), one is encoded with a flag indicatingscheduled or emergency dose, and one is encoded with a flag indicatingdeleting. Alternatively, one may use the programming information thatcontains a medication identifier to indicate a particular medication,and use separate pieces of programming information containing userrequest (one for loading/refilling/modifying, one for emergency dose,one for deleting, etc. for any medication) to indicate the userrequests. Another alternative is that scanning the programminginformation of a user request causes the system to display or announceall existing medications, and the user stops scanning when the desiredmedication is being displayed or announced to indicate selection of themedication. For example, when user needs to delete a medication, he/shescans the programming information for deleting. This causes the systemto display (or announce) all existing medication circularly. When thedesired medication is being displayed (or announced), the user takesaway the programming information. The processing unit understands thatas request for deleting the selected medication, and proceedsaccordingly. It should be emphasized that using these kinds ofprogramming information that has user request does not amount tobypassing the user-request expression or eliminating the user-requestprotocol. Each of these methods of user request expression has certainrules that a user has to follow, which is precisely the user-requestprotocol.

For the user-interface that comprises a microphone and voice-recognitionsystem, the user-request protocol may be using oral commands: “loading”,“emergency”, “deleting”, etc. The oral commands are considered asprogramming information that contains the user requests, since it ismachine-readable. Similarly, for the user-input interface that comprisesa scanner and character-recognition system, users use printed usageinformation (e.g., two tablets at 8:00 AM, 12:00 PM, and 6:00 PM) and“loading”, “emergency dose”, “deleting” (in separate pieces) asprogramming information for user-request expression.

If the system is shared by multiple users (e.g., several members of afamily, or in a healthcare facility), a user control means is needed.The user control means requires a user to present user identifier inpredetermined form for certain types of user requests. Although aconventional user-identification interface such as a keypad or touchscreen can be used for inputting user identifier, the preferred methodis to use another piece of programming information that contains theuser identifier, so that no additional user-input interface is notrequired. Pre-made distinct user identifier (e.g., barcode) may beprovided (color coded or have the user's name printed or written on it).A user uses the programming information that contains the medicationidentifier to indicate a medication (if programming the scheduled eventsis required, encoded or preloaded usage information is required), anduses the programming information that contains the user identifier toexpress a request (e.g., single scan for taking scheduled or emergencydose, double scan for loading, triple scan for deleting, quadruple scanfor user-compliance report). The processing unit registers the useridentifier with medication when the medication is loaded. An alternativeis, the user uses both the programming information that contains theusage information (or uses preloaded usage information) and thatcontains user identifier for loading medication, and uses that containsthe user identifier for all other requests. When the user scans his/heruser identifier, the system displays (or announces) all existingmedications of the user circularly. The user takes away the useridentifier when the desired medication is being displayed (or announced)to indicate selection of a medication. The system then displays (orannounces) all applicable user requests for this medication circularly.The user scans his/her user identifier again when the desired userrequest is being displayed (or announced) to indicate selection of auser request. For devices used in healthcare facilities, the processingunit may be configured to allow only authorized person (identifier) toperform certain operations, just like system administrator for acomputer system.

Another example for user control means is to use a fingerprint reader.The fingerprint of a designated finger (e.g., index finger of righthand) is used as user identifier. The fingerprint is considered asprogramming information, since it is machine-readable and identifies auser, although it requires a separate programming-information reader(the fingerprint reader). A user uses fingerprint just like a useridentifier, as described above.

There are countless similar examples, they all follow the fundamentalidea of the user-request expression of the present invention, namely,presenting (suitable) programming information to theprogramming-information reader in a predetermined manner indicates aspecific user request.

In the preferred embodiment section (and the above description of thissection), it is described that the user interface consists of aprogramming-information reader, and users use programming information(may be multiple pieces) to express all requests. The system can useother (conventional) controls, e.g., a control button (an on-and-offswitch), for user-request expression in conjunction with the programminginformation. Again, there are countless possible user-request protocolsfor such configuration. One example may be: a user uses programminginformation that contains a medication identifier to indicate themedication, then, the user presses the control button once for taking ascheduled or emergency dose, twice for loading (including refilling andmodifying), three times for deleting, four times for user-compliancereport. A touch sensor switch or other equivalence can be used in placeof the control button.

One variation is that the user holds down the control button for onesecond for taking a scheduled or emergency dose, two seconds forloading, three seconds for deleting, four seconds for user-compliancereport.

Another variation is that the first time the programming information isscanned, the processing unit understands it as a loading request andproceeds accordingly. The subsequent scanning of the same programminginformation indicates other requests, and the user presses the controlbutton once (or holds it for one second) for emergency dose, twice (orholds for two seconds) for loading, or three times (or holds for threeseconds) for deleting, and four times (or holds for four seconds) foruser-compliance report.

Yet another variation is that the user scans the programming information(once) for loading medication; for other requests that requireidentifying a medication, the user holds down the control button for apredetermined period of time (e.g., five seconds), which causes thesystem to display or announce all medications currently in the system;when the name of the desired medication is being displayed or announced,the user uses the control button to indicate the request: pressing thecontrol button once for requesting an emergency dose, three times fordeleting the medication, etc. For requests that do not requireidentifying a medication, the control button alone can be used toexpress requests, e.g., pressing the control button once for taking ascheduled dose, four times for user-compliance report.

One exemplary embodiment with control button (as part of the user-inputinterface) is depicted in FIG. 11. The controlled device is anindicator, which has a LCD display 310 and an alarm 320. In this case,the system (control unit plus the controlled device) works as anauto-programming medication reminder. In this exemplary configuration,the processing unit and the controlled device (the indicator) arecombined physically into a device that resembles a digital watch (upperportion of FIG. 11). FIG. 11 depicts that the programming-informationreader 10 is plugged, ready to scan the programming information. Theuser scans the programming information, indicating request for loading.Although this particular embodiment (and some other similar situations)does not require loading the medication (medications may be stored intheir original containers), for consistency the term loading is used. Ifnecessary, the processing unit automatically programs the scheduledevents using the programming information. The user unplugs theprogramming-information reader and wears the auto-programming medicationreminder. Of course, wireless communication between theprogramming-information reader and processing unit can be used as well.

When a scheduled event occurs, the LCD display 310 shows the name andunit dosage of that medication, and the alarm 320 sounds. The userpresses the control button 10B once to stop the alarm and takes themedication. The processing unit records the actual time when theprogramming information is scanned as user-compliance data. For allother requests (emergency dose, deletion, user-compliance report, etc.),the user holds down the control button 10B, which causes the display 310to display all medications circularly. When the desired medication isbeing displayed, the user presses the control button 10B once forrequesting an emergency dose, or three times for deleting themedication.

Another possible configuration is that the processing unit and theindicator (controlled device) are separate and communicate wirelessly,and a user wears the indicator. In this case, theprogramming-information reader and the processing unit may be integratedinto a physical unit. Such configuration is suitable for short-rangeuse, for example, inside and around a house or building. By the way,this exemplary embodiment does not require loading or deletingmedication, hence guided user operation and automatic medication-storagemapping are not used.

Another replacement for control button is a mechanical-electrical lock.The lock may have multiple key positions, one for taking scheduled oremergency dose, one for loading, one for deleting, and one foruser-compliance reporting. A user inserts his/her key to the lock andturns the desired position to make user request. Another variation isthat inserting the key causes the system to display (announce) allcurrent medications of the user. When the desired medication is beingdisplayed, the user turns the key to indicate a selection. The systemthen displays (announces) all applicable user requests for the selectedmedication. When the desired user request is being displayed, the userturns or removes the key to indicate a selection. This embodiment notonly provides an alternative method for user-request expression but alsoenforces security (the lock works as part of the user-input interface aswell as the user control means).

Another example of conventional controls (as part of user-inputinterface) is a depressible scroll wheel (a scroll wheel plus aon-and-off switch). An exemplary user-request protocol may be: user usesprogramming information for loading medication. For all other requests,the user presses the scroll wheel once, which causes the display to show(or a speaker to announce) all medications in the system. The user usesthe scroll wheel to scroll up or down the list to find the desiredmedication and presses the scroll wheel once, indicating a selection.Then, the display shows all applicable requests. The user uses thescroll wheel to find the desired request and presses the scroll wheel toindicate the selection. Since programming information alone issufficient for user to express all requests, these additional controlsare considered as optional controls.

In the preferred embodiment section, it is described that the system ofthe present invention has one programming-information reader. The systemmay also be equipped with multiple programming-information readers, eachfor a different type of programming-information carrier (e.g., barcode,magnetic strip, smart card, etc.). This gives medication providers moreflexibility in choosing their preferred carriers, while giving usersmore flexibility in choosing their medication providers. These may bereplaceable programming-information readers with a universal interfaceto the processing unit. This should not be confused with the redundant(identical) readers required by some prior art designs, which are simplydue to the deficiency of the prior art designs.

FIG. 12 shows the system of the present invention with multiple(different types) programming-information readers and conventionalcontrols. The programming-information readers can be barcode scanner,magnetic card reader, smart card reader, fingerprint reader, microphone,etc. The conventional controls can be control button, touch sensor,lock, scroll wheel, etc. The medication administering device (controlleddevice) can be medication reminder, organizer, dispenser, communicationdevice, computer, etc.

There are countless embodiments for the user-input interface andcorresponding user-request protocols, according to the fundamental ideaof the present invention. A broad spectrum of such examples, fromordinary ones (using barcode, magnetic card, smart card, etc.) toextraordinary once (using human-voice, human-readable text, etc.), tocombination with conventional controls (control button, lock, scrollwheel, etc.), has been described. The general rule is (1) programminginformation that contains medication identifier and usage informationcan be used for all types of user requests; (2) programming informationmedication that contains medication identifier (only) can be used forall types of user requests, except those require programming scheduledevents (which need preloaded usage information); (3) other programminginformation or conventional controls can be used for some requests thatdo not require identifying a medication and programming scheduledevents, otherwise they need help (e.g., programming information thatcontains medication identifier or usage information, or displayed listto chose a medication). The processing unit ignores invalid userrequests (do not conform to the user-request protocol) and inapplicable(e.g., before a new medication is loaded, a user cannot request fordeleting) user requests. And when it gives user choices, it only givesapplicable ones to a given situation.

The system may have multiple sets of user-input interfaces and acceptseveral user-request protocols. For example, the system may have theprogramming-information reader as the primary user-input interface andthe control button as the backup user-input interface.

The new use of (machine-readable) programming information of the presentinvention allows the user to accomplish two tasks at the same time:conveying encoded information and user-request to the system. It allowssimple user-request expression and simple user-input interface. Simpleuser-request expression and simple user-input interface should reducethe possibility of errors considerably. Nevertheless, the system maydisplay or announce the user request as detected by the processing unit,and may be configured to require the user to confirm a request (usingprogramming information or optional controls). Since any operation canbe negated by the opposite operation, e.g., the effect of loading can berestored by a subsequent deleting and vise versa, users can alwayscorrect their mistakes gracefully.

In the preferred embodiment section, most examples describe that theprocessing unit generates control signals when a scheduled event occurs.The processing unit may as well generate control signals in advance toinform the user for future scheduled events. For example, the time,medication, and unit dosage of the next scheduled event may be displayedafter the user takes a scheduled dose.

In the preferred embodiment section, it is described that the actualtime that the programming information is scanned is used asuser-compliance data. Other means can definitely be used to collectuser-compliance data. For example, sensors (e.g., micro switches) thatdetect the opening/closing of compartment or access doors, or physicaldispensing of medication, may be used.

In the preferred embodiment section, it is described that all necessaryuser operations are guided by the system. Obviously, the devicemanufacturer can decide to incorporate certain types of guided useroperations at certain level to achieve desired effects. Depending on itscapability, a particular system may require more, less, same, ordifferent operations than those described in the preferred embodimentsection, but suitable guidance can always be provided to guide the usersto complete the necessary operations following the fundamental idea ofthe present invention.

In the preferred embodiment section, it is described that the userfollows the guidance of the system to load a medication, and theprocessing unit establishes the medication-storage mapping. This is thepreferred method since it solves two major problems for all prior artdesigns at same time. In some embodiments, loading is relatively easy,such as bulk organizer and dispenser, and the user can determine whichcompartment to load a medication to or delete from. In such case, analternative way for automatic medication-storage mapping is to deploysensors to detect which compartment a medication is loaded to or deletedfrom, similar to that in the description of the embodiment shown in FIG.5A. Of course, it is also possible to use the programming informationand/or the optional control (e.g., with a predetermined sequence) toestablish the medication-storage mapping. For example, extend theuser-request protocol to include the storage information (e.g., insteadof requesting to load a medication, requesting to load a medication intoa specific storage). Therefore, these two aspects of the presentinvention (guided user operation and automatic medication-storagemapping), are independent and can be used separately or combined.

In the preferred embodiment section, discrete scheduled events aremostly concerned. Generally speaking, the scheduled events do not haveto be discrete events occurring at discrete moments, but can well becontinuous events as a function of time. Examples may includecontrolling IV or anesthesia delivery with variable rate as function oftime. Although in most cases a scheduled event contains two components:timing and quantity (e.g., unit dosage), in general it may contain anynumber and any type of components. For example, the scheduled event fortake-as-needed medication contains only the quantity, and the scheduledevent for reminding a user to measure blood pressure or glucose may beconsidered to contain only the timing or the timing plus a task(measurement).

In the preferred embodiment section, only the most basic form of thepresent invention is described. The system of the present inventioncertainly can incorporate additional components known in the art to addmore features or detail. Since practically any complicated programmingcan be handled and is done automatically with the present invention, thecorrelation between the increase of features and the increase of userprogramming burden, which always exists with prior art designs, nolonger exists. Furthermore, the present invention incorporates guideduser operations. Therefore, the system of present invention is inadvantageous position than prior art systems to incorporate morefeatures.

For example, security measures may be added, such as secure caps/doorsfor medication storage, in order to prevent opening by children orunauthorized persons. For system used by multiple users, each user(identified by user identifier) can only access his/her own medication.The access doors may be latched and controlled by the processing unit,and the latches are released (or the medication is dispensed) only whenthe correct user identifier is presented (or a key is used).

In the preferred embodiment section, most examples describe a singlecontrolled device. In principle, the method and control unit of thepresent invention can be used to control any number of identical ordifferent devices simultaneously. For example, one control unit controlsall medication administering devices of a household. Furthermore, thefunctions of several devices described in the preferred embodimentsection may be combined (several devices combined), and the control unitcontrols all these functions. If the control unit controls multipledevices wirelessly, Bluetooth technology can be used.

The preferred embodiment section mainly describes the application of thepresent invention to user devices. The method and control unit ofpresent invention can also be applied to control a pharmacy or factory(medication fulfillment) system. Such systems can be viewed aslarge-scale (slightly modified) bulk medication organizers/dispenserswith hundreds or even thousands of storage compartments. The pharmacistsuse a programming information carrier (no schedule is needed) to load ordelete a medication. The system provides guided operations to guide thepharmacists to load and delete the medication. However, there is noschedule involved. So, programming the scheduled events means registerthe necessary information (e.g., medication id, total amount, expirationdate, etc.). The system automatically establishes medication-storagemapping. Another piece of programming information that contains themedication identifier and total quantity, which is generated by thedoctor's computer when the medication is prescribed, may be used forfilling a prescription. Preferably, the previously described one card isused. The pharmacists use the card to request the medication similar torequesting an emergency dose for user device, except that the “emergencydose” means the total amount of the prescribed medication. With featureslike automatic programming (medication and amount), simple user-requestexpressions, guided user operations, and automatic medication-storagemapping (storage registration), the pharmacy or factory system of thepresent invention is advantageous than those prior art pharmacy andfactory systems. A large-scale system may call for a powerful processingunit or a stand-alone computer as the processing unit, but thefundamental idea and concept remain the same.

In the preferred embodiment section, for the sake of clarity, the systemof the present invention is divided into two major components:programming-information reader and the processing unit. It is worth toemphasize again that these are logical divisions and not physicaldivisions. These logical components may be selectively combined, andsome of their sub-components may be shared or moved from one componentto another, as illustrated in the preferred embodiment section.Furthermore, these components should be understood and interpreted inthe broadest context.

Finally, it must be emphasized that the exemplary embodiments are alldesigned to clearly convey the fundamental idea and spirit of thepresent invention. All the exemplary embodiments and components must beinterpreted in the broadest sense, since it is impossible to describeexhaustedly all possible choices. One example will be given here toillustrate such concept: programming information may be downloadeddirectly to the processing unit from the doctor's or pharmacy's computersystem. It could be viewed that there was no programming-informationcarrier and programming-information reader. However, in the contextconsistent with the description of the present invention, it should beunderstood that in this case the programming-information carrier is theelectric wires, light, or radio wave (depending on the transmissionmethod used to download the programming information) that carries thesignal of programming information, and the downloading port and theelectric wires that fetch the signal of programming information to theprocessing unit constitute the programming-information reader. In suchcase the programming-information carrier only carries the programminginformation temporarily. But this is not totally different from theother examples in the preferred embodiment. As mentioned previously,re-writable programming-information carriers may be reused for differentmedications, so they also carry programming information (of a particularmedication) temporarily.

A practical implementation of the example described immediately above isa smart card that contains the processing unit. The doctor's orpharmacy's computer system downloads the programming information intothe smart card (wired or wirelessly). At user's home, the smart cardcontrols the controlled devices (wired or wirelessly, e.g., usingBluetooth technology). The smart card detects all available controlleddevices at user's home, chooses a suitable one for that medication, andguides the user to load the medication into appropriatemagazine/compartment. The medication-storage mapping is automaticallyestablished with loading, and the smart card controls the scheduledevents of the medication. In this case, it is preferable to have anindicator that can display (or announce) all medications in the systemso that user can select a desired one to make applicable requests. Forthis exemplary embodiment, the system has two physical components: smartcard (comprises the programming-information reader and processing unit)and controlled device. Even the two physical components can be furthercombined into one physical unit. A slight different configuration forthis example is that the smart card implements only part of theprocessing unit, with the complementary part as a separate module orbeing integrated with the controlled device. However, this embodimentrequires another programming-information reader or conventional control(with indicator) for user to express user requests.

The above example may sound in some aspect similar to some prior artdesigns, such as pharmacy-provided preprogrammed devices or doctor- orpharmacy-programmed module. It is considerably different from and isadvantageous than those prior art designs, since it incorporates all theadvantages of the present invention, such as flexibility inconfiguration, minimal user-input interface, simple user-requestexpressions, guided user operations, and automatic medication-storagemapping. It is auto-programmed as opposed to having to be programmed bypharmacist. Since it incorporates the guided user operation andautomatic medication-storage mapping, the medication can be easilyloaded by the user as opposed to having to be loaded (modified, deleted,etc.) by pharmacist as those prior art designs.

Conclusion, Ramification, and Scope

The present invention has five aspects. The first aspect of the presentinvention is automatic programming of the scheduled events. Hence userprogramming, user-programming interface, and user programming errors areall eliminated. The second aspect is simple user-request expression.Hence user input and the user-input interface are further reduced andsimplified. The third aspect is guided user operation. The system guidesthe user to complete necessary operations corresponding to user request.Hence user operations are significantly simplified. The forth aspect isautomatic medication-storage mapping. Hence the user no longer has tomanually establish medication-storage mapping, and the user-inputinterface is further reduced. The fifth aspect is no clock setting.Hence clock-setting interface is eliminated and the user-input interfaceis further reduced. Prior art systems typically require the user tofigure out a loading-scheduling plan, follow the plan to load themedications, and tell the system how the medications are stored andtheir scheduled events. The system of the present invention does theopposite: it figures out the loading-scheduling plan, guides the user toload the medications, establishes medication-storage mapping, andprograms the scheduled events, all automatically.

The present invention can be used virtually with any type of medicationadministering devices (the preferred embodiment section describes alltypical types), and can satisfy any needs. The more complicate theschedules, the more benefit the present invention provides.

The fundamental idea of the present invention can be apply to otherareas that need to program and control any kind scheduled events,discrete or continuous. Examples may include dispensing parts/componentsin a factory assembly line, feeding ingredients/chemicals in food orchemical industry, control flow rate of a fluid (continuous function oftime), controlling experiments in labs, or pet food/nutrition supplementdispensing. Incidentally, using (only) machine-readable programminginformation can prevent giving away business secret (e.g., recipe,composition, timing, and condition). The simple user-requestexpressions, guided user operations, and automatic medication-storagemapping will further improve the operation of these systems. Obviously,when the present invention is applied to more complex controls, everyaspect (e.g., the scheduled events, types of operations) becomes morecomplex than that for controlling medication administering device, butthe fundamental concept and the method remain the same. All suchapplications are within the scope of the present invention. For thegeneral application of the present invention, the term “object” shouldbe used in place of “medication” (e.g., object identifier,object-storage mapping, etc.), and most descriptions should apply to thegeneral applications. For general applications, the scheduled event maycontain timing, quantity, number, length, area, volume, temperature,pressure, flow rate, speed, acceleration, force, torque, voltage,current, field strength, frequency, or any task. Also, the user requestsfor different objects are different, and the operation corresponding tothe requests are also different, but they all follow the same pattern asdescribed.

In conclusion, the system of the present invention provides thefollowing advantages over the prior art designs:

-   -   (1) It satisfies all practical needs for medication management        and administration (overcomes prior art disadvantages A1 and        G5).    -   (2) It automatically programs the schedules and unit dosages of        medications, hence eliminating user programming,        user-programming interface, and user-programming error        (overcomes prior art disadvantages B1, C2, D3, E2, and E3).    -   (3) It automatically tracks the scheduled events and takes        appropriate actions when a scheduled event occurs (overcomes        prior art disadvantages A2, A3, B7, and B8).    -   (4) It allows users to express requests with very simple manner        and has a minimal user-input interface (overcomes prior art        disadvantage J1).    -   (5) It guides the user to complete all necessary user operations        (overcomes prior art disadvantages B2, B3, B5, B6, D1, E4, J2).    -   (6) It automatically establishes medication-storage mapping        without any additional user effort (overcomes prior art        disadvantages E5 and J3).    -   (7) It does not require clock setting and clock-setting        interface (overcomes prior art disadvantages C1, E1, and I12).    -   (8) It has a minimal user-input interface, requires minimum and        simple user operations, and reduces the user-operation errors        associated with prior art designs (overcomes a common        disadvantage of all prior art designs).    -   (9) It can be used by any number of users, can control any        number of devices, can handle any number of medications, with        any precise timings, any different schedules, and any complex        schedules (overcomes prior art disadvantages B4, D2, I4).    -   (10) Vision-impaired users and other users that are excluded by        prior art systems and devices can easily use (solves a        long-standing problem for all prior art devices).    -   (11) It is so easy to use hence there is no longer a need for        professional assistance or have medications prepackaged        (overcomes prior art disadvantages F2 to F13, G1, G2, I7, and        H6).    -   (12) Users are not required to subscribe to any organization for        managing their medications and no large supporting system is        needed (overcomes prior art disadvantages H1 to H7).    -   (13) It does not require redundant components (overcomes prior        art disadvantages I5, I6, and I8).    -   (14) It can be adopted for all types of medication administering        devices (overcomes prior art disadvantage I9).    -   (15) It basically has no restrictions on configuration,        dimension, interconnection among its components, and detailed        design of the controlled device, hence gives the device        manufacturers maximum freedom in design their devices (overcomes        prior art disadvantages I2, I3, I10 and I11).    -   (16) It does not require medication providers to drastically        change their routines, equipments, or medication packages        (overcomes prior art disadvantages G3 and I1).    -   (17) Users can freely choose their medication providers and        medication administering devices (overcomes prior art        disadvantage F1).    -   (18) It is of low cost (no subscription and maintenance fee) to        users (overcomes prior art disadvantages G4).

The five aspects of the present invention, namely, automatic programmingof scheduled events, simple user-request expression, guided useroperation, automatic medication-storage mapping, and no clock setting,can be selectively combined (some of them can be applied separately) toachieve certain effects or satisfy certain requirements. Each of themovercomes a number of the aforementioned prior art disadvantage. Each ofthem reduces or simplifies the physical complexity, the components, andthe user operations. Each of them reduces potential errors associatedwith the prior art designs. Combining all these aspects together, thepresent invention overcomes all aforementioned disadvantages of theprior art designs, significantly simplifies or reduces the complexity,the components, the operations, and the potential operation errors ofthe prior art designs, and greatly simplifies the user operations,resulting a truly accurate, highly automatic and user-friendly system.Due to its high level of automation and ease of use, vision-impairedusers and other users that are excluded by prior art systems can easilyuse the system of the present invention.

Furthermore, the present invention basically has no restriction onconfigurations, dimensions, or detailed designs of the components of thesystem. The components can be separate or selectively integrated. Thecomponents can communicate through any suitable wired or wirelesscommunication links. Some sub-components can be shared or moved around.No prior art method or system has such broad range of application andsuch flexibility. No prior art designs or combination of them providesso many advantages. No prior art design provides such level ofautomation, has such simple user-input interface, and is so easy to use.

The method and control unit of the present invention can make asignificant impact if it is widely adopted and standard protocols areestablished. Device manufacturers can design their devices whatever waythey want. They can even choose to make modules of part of the system towork with the complementary modules made by others, and the onlyrequirement is that they all follow the standard protocols. Medicationproviders can choose whatever package and container they want.Programming information can come from doctors, medication providers, orpre-made templates or preloaded ones can be used. Users can get theirmedication from any medication provider, and choose any device theylike.

Given the exemplary embodiments, numerous alternations, substitutions,modifications, and ramifications will become obvious to the skilled inthe art. The present embodiments therefore should be considered in allrespects as illustrative and not restrictive. All alternations,substitutions, modifications, and ramifications that come within themeaning and range of equivalency of the present invention are covered bythe scope of the present invention. The scope of the present inventionshould be determined not by the exemplary embodiments just described,but by the following claims.

1. A method for programming and controlling scheduled events for atleast one object, comprising the steps of: (a) providing at least onepiece of programming information encoded in machine-readable formataccording to a predetermined encoding protocol, (b) providing aprogramming-information reader that is capable of reading the encodedprogramming information and converting it into appropriateprogramming-information signals, (c) providing a user-request protocolwhere presenting said programming information to saidprogramming-information reader in a predetermined manner indicates aspecific user request, (d) providing a processing unit that couples tosaid programming-information reader, said processing unit being capableof decoding said programming information from saidprogramming-information signals according to said encoding protocol,said processing unit being capable of detecting said user requestsaccording to said user-request protocol, said processing unit takingpredetermined actions according to said user request, said programminginformation containing useful information for certain types of said userrequests, said processing unit selectively using said programminginformation for said certain types of said user requests, (e) presentingsaid programming information to said programming-information reader in apredetermined manner conforming to said user-request protocol to expresssaid user request, said processing unit programming said scheduledevents if required, said processing unit storing said scheduled eventsand generating control signals for each said scheduled event, (f) saidcontrol signals being used to control predetermined device that takespredetermined actions in response to said control signals, whereby auser uses said programming information to express various said userrequests in simple manners conforming to said user-request protocol,said programming-information reader constitutes the user-inputinterface, said scheduled events are programmed automatically, and saidcontrol signals are used to control said scheduled events.
 2. The methodof claim 1 wherein said programming information contains objectidentifier of at least one said object, and said processing unit furtherhas preloaded information with object identifiers for a plurality ofobjects, said preloaded information containing useful information forcertain types of said user requests concerning said object, saidprocessing unit further selectively using preloaded information withmatching object identifier for said certain types of said user requestsconcerning said object.
 3. The method of claim 1 wherein said processingunit further generates guiding signals for at least one type of saiduser requests, said guiding signals being used to drive a guiding meansthat guides the user to complete predetermined user operationscorresponding to said user request.
 4. The method of claim 1 whereinsaid object is a substance stored in a storage and said scheduled eventconcerns releasing certain amount of said substance at certain time,said processing unit further establishing object-storage mapping forsaid substance when said substance is loaded to said storage.
 5. Acontrol unit for controlling at least one medication administeringdevice, comprising: (a) a programming-information reader that is capableof reading programming information encoded in machine-readable formataccording to a predetermined encoding protocol and converting it intoappropriate programming-information signals, (b) a processing unit thatcouples to said programming-information reader and said medicationadministering device, said processing unit being capable of decodingsaid programming information from said programming-information signalsaccording to said encoding protocol, (c) said processing unit beingcapable of detecting user requests according to a predetermineduser-request protocol where presenting said programming information tosaid programming-information reader in a predetermined manner indicatesa specific user request, said processing unit taking predeterminedactions according to said user request, said programming informationcontaining useful information for certain types of said user requests,said processing unit selectively using said programming information forsaid certain types of said user requests, (d) said user requestsincluding at least loading medication and said processing unitprogramming the scheduled events for said medication if required, saidprocessing unit storing said scheduled events and generating controlsignals for each said scheduled event, (e) said medication administeringdevice taking predetermined actions in response to said control signals,said predetermined actions including at least one selected from thegroup consisting of producing alarm, indicating said medication,indicating unit dosage of said medication, indicating time, indicatingstorage of said medication, dispensing unit dose of said medication, andindicating said scheduled event, whereby a user uses said programminginformation to express said user requests in simple manners conformingto said user-request protocol, said scheduled events are programmedautomatically, and said control unit controls said medicationadministering devices to take predetermined actions for each saidscheduled event.
 6. The control unit of claim 5 wherein said programminginformation contains medication identifier of at least one saidmedication, and said processing unit further has preloaded informationwith medication identifiers for a plurality of medications, saidpreloaded information containing useful information for certain types ofsaid user requests concerning said medication, said processing unitfurther selectively using preloaded information with matching medicationidentifier for said certain types of said user requests concerning saidmedication.
 7. The control unit of claim 5 wherein said medicationadministering device comprises at least one device selected from thegroup consisting of medication reminder, bulk medication organizer,dose-compartment medication organizer, bulk medication dispenser,dose-compartment medication dispenser, prepackaged medication dispenser,communication device, and computer.
 8. The control unit of claim 5, apredetermined number of user-operable controls are further provided,said user-operable control coupling to said processing unit and beingused for user to express said user requests in conjunction with saidprogramming information.
 9. The control unit of claim 5 wherein saidprocessing unit further generates guiding signals for at least one typeof said user requests, said medication administering device furtherproduces predetermined guidance in response to said guiding signals toguide the user to complete predetermined user operations correspondingto said user request, said predetermined guidance including at least oneselected from the group consisting of indicating said medication,displaying image of said medication, indicating the storage for loadingsaid medication, indicating the amount of said medication to be loaded,indicating the storage for removing said medication, indicating theamount of said medication to be loaded, indicating the amount of saidmedication to be removed, and dumping certain amount of said medication.10. The control unit of claim 5 wherein said processing unit selectivelyrecords predetermined indication of medication consumption asuser-compliance data and generates user-compliance reports based on saiduser-compliance data and said scheduled events, said user requestsfurther include request for said user-compliance report, said processingunit further controls an output device for outputting saiduser-compliance report.
 11. The control unit of claim 5 wherein saidmedication administering device comprises a plurality of storagecompartments, said processing unit further generates guiding signals atleast for loading said medication, and said medication administeringdevice further produces guidance in response to said guiding signals toguide the user to complete predetermined user operations correspondingto loading said medication, said guidance including at least oneselected from the group consisting of indicating the storage compartmentfor loading said medication, opening the access door of the storagecompartment for loading said medication, and docking a common accessdoor to the storage compartment for loading said medication, saidprocessing unit further establishing medication-storage mapping for saidmedication.
 12. The control unit of claim 5 wherein said medicationadministering device comprises a plurality of storage compartments, saidstorage compartments being equipped with sensors coupling to saidprocessing unit, each said sensor being capable of detecting of loadingsaid medication to the corresponding storage compartment, saidprocessing unit further establishing medication-storage mapping for saidmedication.
 13. The control unit of claim 5 wherein said medicationadministering device further comprises a communication device thatcommunicates information with at least one remote device, saidinformation including at least one type selected from the groupconsisting of information about predetermined scheduled event,information about predetermined medication, information aboutpredetermined incompliant event, information about predetermined errorcondition, said programming information, and user-compliance report. 14.The control unit of claim 5 further comprises a user control means thatrequires a user to present a user identification of predetermined formfor certain types of said user requests.
 15. The control unit of claim 5wherein said processing unit comprises a clock of the type selected fromthe group consisting of pre-set clock, radio-controlled clock, andrelative-time clock, whereby users do not have to set said clock, andclock-setting interface is eliminated.
 16. A control unit that controlsat least one medication administering device, comprising: (a) aprogramming-information reader that is capable of reading programminginformation encoded in machine-readable format according to apredetermined encoding protocol and converting it into appropriateprogramming-information signals, (b) a processing unit that couples tosaid programming-information reader and said medication administeringdevice, said processing unit being capable of decoding said programminginformation from said programming-information signals according to saidencoding protocol, (c) said processing unit being capable of detectinguser requests according to a predetermined user-request protocol wherepresenting said programming information to said programming-informationreader in a predetermined manner indicates a specific user request, saidprogramming information containing information sufficient to programsaid scheduled events, said processing unit taking predetermined actionsaccording to said user requests, (d) said user requests including atleast loading medication, said processing unit selectively using saidprogramming information to program said scheduled events if required,said processing unit storing said scheduled events and generatingcontrol signals for each said scheduled event, (e) said medicationadministering device taking predetermined actions in response to saidcontrol signals, said predetermined actions including at least oneselected from the group consisting of producing alarm, indicating saidmedication, indicating unit dosage of said medication, indicating time,indicating storage of said medication, indicating scheduled event, anddispensing a unit dose of said medication, whereby a user expresses saiduser requests in simple manners conforming to said user-requestprotocol, said scheduled events are automatically programmed, and saidcontrol unit controls said medication administering devices to takepredetermined actions for each said scheduled event.
 17. The controlunit of claim 16 wherein said programming information is of the typeselected from the group consisting of prescription-generator provided,medication-provider provided, and pre-made template.
 18. The controlunit of claim 16, a predetermined number of user-operable controls arefurther provided, said user-operable control coupling to said processingunit and being used for user to express said user requests inconjunction with said programming information.
 19. The control unit ofclaim 16 wherein said processing unit further generates guiding signalsfor at least one type of said user requests, said medicationadministering device further generates guidance in response to saidguiding signals to guide the user to complete predetermined useroperations corresponding to said user request, said guidance includingat least one selected from the group consisting of indicating theappropriate storage compartment for loading said medication, opening theaccess door of the appropriate storage for loading said medication,docking the common access door to the appropriate storage for loadingsaid medication, indicating said medication, indicating unit dose ofsaid medication, indicating the storage for said medication, indicatingthe storage for removing said medication, and dumping deletedmedication.
 20. The control unit of claim 16 wherein said processingunit further establishes medication-storage mapping when said medicationis loaded.